Labeling requirements for medicinal products for human use and veterinary medicinal products. Packaging of medicinal products What is the primary packaging of a medicinal product

Contents

Requirements for the labeling of medicines for medical use and veterinary medicinal products

General provisions

These Requirements establish the rules for labeling placed on the packages of medicinal products for medical use (hereinafter referred to as medicinal products) and veterinary medicinal products (hereinafter referred to as veterinary medicinal products) put into circulation on the common market of medicinal products within the Eurasian economic union(hereinafter referred to as the Union).
Labeling of medicines (veterinary medicines) is applied to the packaging in Russian and, if there are relevant requirements in the legislation of the Member States of the Union (hereinafter referred to as the Member States), in the state language (state languages) of the Member State in whose territory the medicines (veterinary medicines) are sold. funds). Additional use of other languages is allowed provided that the information is completely identical. Labeling of medicinal products (veterinary drugs) should not contradict or distort the information contained in the documents of the registration dossier, and be of an advertising nature.
Labeling of medicinal products (veterinary products) must be easy to read, legible, understandable and reliable and not mislead consumers (purchasers) of the medicinal product and veterinary medicinal product (hereinafter referred to as the veterinary drug).
For the purposes of these Requirements, concepts are used that mean the following:

"secondary (consumer) packaging"- packaging in which the medicinal product (veterinary drug) is placed in primary or intermediate packaging for sale to the consumer;
"marking"- information printed on the packaging medicinal product(veterinary remedy);
"primary (inner) packaging" - packaging that is in direct contact with the medicinal product (veterinary product);
"intermediate packaging"- packaging in which the primary packaging can be placed in order to additionally protect the medicinal product ( veterinary drug) or based on the characteristics of the use of the medicinal product (veterinary drug);
"package"- a material or device that guarantees the preservation of the quality of the medicinal product (veterinary product) throughout the established shelf life (storage), ensures the protection of the medicinal product (veterinary product) from damage and loss, and also protects the environment from pollution;
"cell contour packaging (blister)"- flexible packaging with a drug (veterinary drug) in molded cells, from which the drug (veterinary drug) is extracted by extrusion.

Other concepts are used in the meanings defined by international treaties and acts constituting the law of the Union.

The requirements for samples and layouts of packages are established by the rules for registration and examination of medicinal products for medical use, approved by the Eurasian Economic Commission (hereinafter referred to as the Commission).

General marking requirements

5. The primary (inner) packaging (hereinafter referred to as the primary packaging) of a medicinal product (veterinary drug) (with the exception of a medicinal product (veterinary drug) that is a packaged medicinal herbal raw material) shall contain the following information:

b) international non-proprietary name (hereinafter - INN) (if any) or common (grouping) name;
c) dosage form;
d) dosage and (or) activity and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
e) the amount of the medicinal product (veterinary drug) in the package;
e) route of administration;
g) the name or logo of the holder of the registration certificate or the manufacturer (if necessary) of the medicinal product (name or logo of the holder of the registration certificate of the veterinary drug);
h) serial number;
i) expiration date (“best before…”).

On the primary package in the form of a blister pack (blister) (hereinafter referred to as the blister pack), which is placed in a secondary (consumer) package (hereinafter referred to as the secondary package), it is allowed not to indicate the information provided for in subparagraphs "c" and "e" of paragraph 5 of these requirements.
On the primary packaging of small size (total area of the text field is not more than 10 cm 2), on which it is impossible to place all the necessary information, it is allowed not to indicate the information provided for in subparagraphs "b", "c" and "g" of paragraph 5 of these Requirements.
The following information shall be indicated on the secondary packaging, and in its absence, on the primary packaging of the medicinal product (veterinary drug):

a) trade name of the medicinal product (veterinary drug);
b) INN (if any) or common (grouping) name;
c) the name of the holder of the registration certificate and the manufacturer of the medicinal product (the name of the holder of the registration certificate and the manufacturer of the veterinary drug);
d) address of the marketing authorization holder and the manufacturer of the medicinal product (address of the marketing authorization holder and the manufacturer of the veterinary product);
e) dosage form;
f) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
g) the amount of the medicinal product (veterinary drug) in the package;
h) information on the composition of the medicinal product (veterinary drug);
i) series number;
j) production date;
k) expiry date (“best before…”);
l) storage conditions and, if necessary, transportation conditions;
m) route of administration;
o) vacation conditions;
o) warning labels;
R) registration number(for veterinary drugs).

For drugs manufactured both with and without a preservative, when producing products without a preservative after the list excipients the following information is indicated on the secondary packaging: “Contains no preservative”.
Intermediate packaging that does not allow reading the information on the primary packaging without violating its integrity must at least repeat the information indicated on the primary packaging.
The following information is indicated on the packaging of active pharmaceutical ingredients:

a) trade name of the active pharmaceutical substance (if any);
b) INN or common (grouping) name;
c) name and address of the manufacturer of the active pharmaceutical ingredient;
d) series number;
e) production date;
f) the amount of active pharmaceutical substance in the package;
g) expiration date (“best before…”) or, if applicable, retest date;
h) storage conditions;
i) appointment.

For kit (drug (veterinary product) with solvent (diluent)) or kit (set of 2 or more medicines(veterinary drugs)) the following information is additionally indicated on the secondary packaging:

a) information about the components of the kit (set):

names of components;
dosage and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
composition information;
amount;
series number (in accordance with paragraphs 28 and 29 of these Requirements);

b) information about the presence of auxiliary medical devices(syringes, swabs, injection devices, etc.).

It is not allowed to put on the packaging selective information specified in the sections "clinical data" and "pharmacodynamic properties" of the general characteristics of this medicinal product and equivalent sections of the instructions for medical use (leaflet) of this medicinal product.

It is allowed to put on the packaging the text of the instructions for medical use (leaflet) of the medicinal product and the text of the instructions for use (leaflet) of the veterinary drug.

It is allowed to place additional information on the secondary packaging of the medicinal product (veterinary drug), provided that it complies with the documents of the registration dossier.

It is allowed to place a barcode, holographic and other security signs, stickers on the packaging, duplication of the labeling text using other languages and Braille, placement of symbols or pictograms that help explain information about the medicinal product (veterinary drug) to the consumer (purchaser).

If there are sachets (or tablets) with a desiccant in the intermediate or secondary packaging of the medicinal product, they must be marked with a warning label of the appropriate content.

The following information is indicated on the transport container of the package of bulk products:

a) trade name of the medicinal product (veterinary drug);
b) dosage form;
c) INN (if any) or common (grouping) name;
d) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
e) name of the manufacturer, address of the manufacturer of the medicinal product (veterinary drug);
f) the amount of the medicinal product (veterinary drug) in the package and (or) the number of packages in the shipping container;
g) storage conditions and, if necessary, transportation conditions;
h) serial number;
i) production date;
j) expiry date (“best before…”).

If necessary, the logo of the manufacturer of the product, warning labels and manipulator signs can be indicated.

Label text requirements

The trade name of the medicinal product (veterinary drug) is indicated on the packaging in the nominative case.

For medicinal herbal preparations that are packaged medicinal herbal raw materials, the name of the medicinal herbal raw material or active pharmaceutical ingredient is additionally indicated. plant origin on the Latin(except for the name of the fees) in the plural (with the exception of the words "grass" and "bark") and the type of packaged product (for example, "whole", "ground", "powder", etc.).

INN of active pharmaceutical substances in the composition of a medicinal product (veterinary drug) is indicated in Russian in the nominative case and English language(in accordance with the English version of the INN list World Organization healthcare).

In the absence of an INN, the generally accepted (grouping) name in Russian in the nominative case is indicated.

It is allowed not to indicate the INN or the generally accepted (grouping) name of medicinal products (veterinary drugs) in case of its complete coincidence with the trade name.

In relation to heterologous sera, the type of animal from whose blood or plasma they are obtained is indicated.

For medicinal products (veterinary drugs) of biological origin, in the absence of an INN or a common (grouping) name, the source of obtaining the drug is indicated.

For radiopharmaceutical medicinal products (veterinary drugs), the symbol of the chemical element with the index of the radionuclide and the international symbol of radioactivity are indicated.

The names of the holder of the registration certificate and the manufacturer of the medicinal product (names of the right holder of the registration certificate and the manufacturer of the veterinary drug) are indicated in the nominative case. If several manufacturers are involved in the production, the name of the manufacturer performing the release quality control of the medicinal product (veterinary product) must be indicated.

If the names of the holder of the registration certificate and the manufacturer of the medicinal product (the names of the right holder of the registration certificate and the manufacturer of the veterinary drug) coincide, only the name of the holder of the registration certificate of the medicinal product (the right holder of the registration certificate of the veterinary drug) is indicated.

If necessary, the name of the organization carrying out the packing and (or) packaging is indicated, with the preceding word “packaged” and (or) “packed”, “packer”.

Addresses are indicated in abbreviated form (country or country and city) or in full; telephone, fax, e-mail addresses are additionally allowed.

If the holder of the registration certificate of the medicinal product (the right holder of the registration certificate of the veterinary drug) is the manufacturer of the medicinal product (veterinary drug), only the address of the holder of the registration certificate of the medicinal product (the right holder of the registration certificate of the veterinary drug) is indicated.

The dosage, and (or) activity, and (or) concentration of the active pharmaceutical substance (active pharmaceutical substances) are indicated with the obligatory indication of units of measurement.
The amount of the medicinal product (veterinary product) in the package is indicated by weight, volume or number of dosage units, depending on the dosage form and type of package.

For medicinal herbal preparations, which are packaged medicinal herbal raw materials, the mass of medicinal herbal raw materials and (or) active pharmaceutical ingredients of plant origin is indicated at their specific moisture content.

The dosage (activity) of a biological medicinal product is expressed in accordance with the requirements for the instructions for the medical use of medicinal products and general characteristics medicinal products for medical use approved by the Commission.

For radiopharmaceutical medicinal products (veterinary medicinal products), the number of units of radioactivity in the dose or primary packaging is indicated.

Active pharmaceutical substances (components) and their quantity are indicated in the composition of medicinal products (veterinary drugs).
Auxiliary substances (components) are mandatory indicated in the following cases:

a) for medicinal products (veterinary drugs) for oral administration on the secondary packaging, if they are included in the list of excipients indicated on the secondary packaging of medicinal products (veterinary drugs) for oral administration, in accordance with the Appendix to these Requirements;
b) for drugs (veterinary drugs) for injection, on the secondary packaging in full composition without indicating their quantity;
c) for medicinal products (veterinary drugs) for inhalation on the secondary packaging in full composition without indicating their quantity;
d) for medicinal products (veterinary drugs) for local and (or) external use on the secondary packaging in full composition without indicating their quantity;
e) for medicinal products (veterinary drugs) used in ophthalmology on the secondary packaging in full composition without indicating their quantity;
e) for infusion solutions in secondary and primary packaging in full.

The holder of the registration certificate of the medicinal product (the right holder of the registration certificate of the veterinary drug) has the right to indicate full squad excipients (components) on packages.

For infusion solutions, the theoretical value of osmolarity (osmolality) is indicated on the primary and secondary packages.

For immunological drugs (veterinary drugs), the quantitative content of preservatives, sorbents and adjuvants is indicated on the secondary packaging.

The composition of homeopathic medicines (veterinary medicines) is indicated in accordance with the terminology adopted in homeopathy: the names of homeopathic pharmaceutical substances are given in Latin with an indication of the scale and degree of their dilution, the names of excipients are given in Russian according to the documents of the registration dossier.
For medicinal herbal preparations (veterinary preparations), which are packaged medicinal plant raw materials, the composition is indicated only for fees.
References to quality control standards for active pharmaceutical ingredients and (or) excipients are not indicated.
The production date may be omitted if it is included in the batch number.
For a set (medicinal product (veterinary drug) with a solvent (diluent)) or set (set of 2 or more medicinal products (veterinary drugs)) in addition to the secondary packaging, serial numbers of all medicinal products (veterinary drugs) included in the kit (set ), or the serial number of the kit (set).
When applying the date of expiration of the medicinal product (veterinary drug), the month and year are indicated on the package (in this case, when specifying the month, the expiration date means the last day of the indicated month).

If necessary, the period and storage conditions of the medicinal product (veterinary drug) after the first opening of the primary packaging or the period and storage conditions after preparation or dilution of the solution (suspension) are indicated in accordance with the instructions for use of the medicinal product (veterinary drug) and data on stability studies, taking into account provisions established by the requirements for the instructions for the medical use of medicinal products and the general characteristics of medicinal products for medical use.

For a kit (drug (veterinary drug) with a solvent (diluent)) or kit (set of 2 or more medicinal products (veterinary drugs)) the production dates of each component or a single release date of this kit (kit), as well as the expiration date of each component, or a single expiration date of the kit (set) is indicated.

If the expiration dates of each component separately are indicated, then the expiration date of the kit (set) is determined by the earliest expiration date of the components included in the kit (set).

For medicinal herbal preparations (veterinary preparations), which are packaged medicinal plant materials, a method for preparing aqueous extracts is given, indicating the storage conditions and shelf life of the aqueous extract.
The route of administration (route of administration, method of administration) is indicated in accordance with the general characteristics of this medicinal product and the instructions for use of this veterinary medicinal product. The route of administration (method of administration) is not indicated if it is included in the name of the dosage form. It is allowed not to indicate the route of administration for tablets and capsules intended for oral administration.

It is allowed to put an inscription with the following content: “Method of use: see instructions for medical use (leaflet)” for a medicinal product or “Method of use: see instructions for use (leaflet)” for a veterinary drug.

On the primary packaging of small sizes (total area of the text field is not more than 10 cm), on which it is impossible to place all the necessary information, it is allowed to use the following generally accepted abbreviations for the route of administration of injectable drugs (veterinary drugs): “in / in” (intravenous administration), “ i / m "(intramuscular injection)," p / c "(subcutaneous injection).
If there is a sufficient text field on the package, it is preferable to apply full information about the method of using the drug in accordance with the general characteristics of this drug, and the veterinary drug - in accordance with the instructions for its use.
Features of labeling of medicinal products (veterinary drugs) related to narcotic drugs, psychotropic substances and their precursors are established in accordance with the legislation of the Member States.
The conditions for dispensing a medicinal product are indicated in accordance with the category of dispensing approved during registration, assigned taking into account the rules for determining categories of over-the-counter and prescription drugs approved by the Commission, and the conditions for dispensing a veterinary drug - in accordance with the instructions for its use.

For drugs (veterinary drugs) sold only for hospitals, the following information is indicated on the package: “For hospitals”, while the indication “by prescription” (“without a prescription”) is not given.

The following warning labels and symbols must be applied to the secondary packaging:

a) “Keep out of the reach of children”;
b) "Sterile" (for sterile medicinal products (veterinary products));
c) “Antibodies to HIV-1, HIV-2, hepatitis C virus and hepatitis B surface antigen were not detected” (for medicines derived from human blood, blood plasma, organs and tissues);
d) "Homeopathic" (for homeopathic medicines (veterinary medicines));
e) sign of radiation hazard (for radiopharmaceutical drugs (veterinary drugs));
f) "Products passed radiation control"
(for medicinal preparations (veterinary preparations), which are packaged medicinal plant materials);
g) "For veterinary use" (for veterinary drugs).

If necessary, other inscriptions and symbols of a warning nature are applied to the packaging, if they are provided for in the regulatory document on the quality of the drug.

The labeling of a homeopathic medicinal product registered under a simplified registration procedure (in accordance with the rules for registration and examination of medicinal products for medical use) should contain only the following (and no other) information:

a) the scientific name of the homeopathic tincture(s) indicating the degree of its (their) dilution (using the symbols of the pharmacopoeia, which is indicated for this registration procedure for homeopathic medicinal products in accordance with the rules for registration and examination of medicinal products for medical use). If a homeopathic medicinal product consists of 2 or more homeopathic tinctures, it is allowed to supplement the scientific name of the tinctures with a trade name;
b) the name and address of the marketing authorization holder and, where appropriate, the manufacturer;
c) the route of administration and, if necessary, the route of administration;
d) expiration date (month and year);
e) dosage form;
e) release form;
g) special storage conditions (if any);
h) special warning (if necessary);
i) manufacturer's serial number;
j) registration number (for veterinary drugs);
k) entry: “Homeopathic medicinal product without an approved indication for use”;
l) a warning about the need to see a doctor if the symptoms of the disease persist.

Requirements for marking methods

39. In the labeling of medicinal products (veterinary drugs), the color of inscriptions, signs, symbols must be contrasting with the background on which the labeling is applied. The method of marking should ensure its safety during the entire shelf life of the medicinal product (veterinary product) subject to the established storage conditions. It is allowed to apply the series number, production date, expiration date by embossing (symbols have a background color).

The requirements for the preparation and layout of instructions for medical use, established by the requirements for instructions for the medical use of medicinal products and the general characteristics of medicinal products for medical use, are also applicable to the labeling of medicinal products. It is recommended that the size of all characters in the labeling of medicinal products (veterinary drugs) be at least 7 points (or a font size in which the height of the lowercase "x" is at least 1.4 mm), and the distance between lines is at least 3 mm. Text on small packages should have the largest possible font size in order to reduce the likelihood of application errors.

The available surface of the primary and secondary packaging of medicinal products (veterinary products) should be made the best use of. Important information for correct and safe application medicinal product (veterinary drug) should be indicated in the largest possible font size on the most optimal surfaces of the packages.

Drug name, dosage and, if applicable, general content active pharmaceutical substance, as well as the route of administration must be placed in the same field of view, using the largest possible font size. If it is impossible to reflect all the critical information in one field of view on a small package, it is allowed to place them in different fields. To preserve the readability of the information presented, it is necessary to use rational spacing between lines and spaces between words in relation to the size of the font used.

If there is space on the primary and secondary packaging, it is allowed to indicate the logos and pictograms of the pharmaceutical company (manufacturer), provided that they do not violate the legibility of the mandatory information.
In order to ensure the correct identification and selection of a medicinal product (veterinary drug) by consumers (purchasers), as well as with limited space on the package, it is possible to use innovative methods when developing the package design.
Glare-creating glossy, metallic or other packaging that impairs legibility should be avoided. Use not recommended various colors font in the name of the medicinal product (veterinary product) or in individual letters (symbols) of the name, as this negatively affects the correct recognition of the medicinal product.

In order to avoid the risk of misuse of the medicinal product (veterinary drug) due to the similarity of its packaging with the packages of other medicinal products (veterinary drugs), special color identification of the package and other methods that increase the visual distinction of the packages should be used. The number of colors used in the packaging design should be rationally justified in order to minimize the possibility of confusion by consumers (purchasers) of the medicinal product (veterinary product). To ensure the correct identification and use of the medicinal product (veterinary drug) by consumers (purchasers), when marking the primary packaging, the same color design should be used as when marking the secondary packaging.

Labeling should be the same for medicinal products

(veterinary drugs) put into circulation in the territories of the Member States. If there is different information (dispensing conditions, etc.), it is indicated using an additional label (sticker) in a specially designated field of the secondary packaging. If the secondary packaging has a field intended for special information of the Member State, it is allowed to include such information (for example, different status of dispensing from the pharmacy chain or special information: “packaging for hospitals”, “according to government programs", etc.) without using a label (sticker).

The size of the field for placing stickers should not exceed 1/6 of the total area of the secondary packaging, while this field should not cover the information originally printed on the secondary packaging.

For orphan drugs, as well as for individual drugs, in agreement with the authorized body of the Member State that carries out the registration of such a drug, it is allowed to apply labeling using an additional label (sticker).
When marking different dosages (concentrations, etc.) of medicinal products produced in the form of one dosage form, a different color solution or another method should be provided that provides a clear visual identification of the dosage (concentration, etc.).

Different dosages of the same medicinal product (veterinary drug) should be reported in the same way (eg 250 mg, 500 mg, 750 mg, 1000 mg, not 1 g). It is not allowed to indicate trailing zeros in the fractional part of the dosage (2.5 mg should be indicated, not 2.50 mg). Do not use a decimal separator (comma) if it can be avoided (should be 250 mg, not 0.25 g). For security reasons, it is necessary to write the word "microgram" in full, and not abbreviate it. However, in some cases, if difficulties arise that cannot be eliminated by reducing the font size, it is allowed, if there are justifications and there are no security concerns, to use the abbreviated form "mkg".

The route of administration must match that specified in the general characteristics of this medicinal product or the instructions for use of this veterinary drug and strictly comply with standard terms. Negative expressions should not be used (for example: "Not for intravenous administration"). Only standard abbreviations are allowed (for example, i/v, i/m, s/c). Other non-standard routes of administration should be specified in full. If patients are unfamiliar with the route of administration, explanations should be given in the instructions for medical use of the medicinal product. This is especially important for drugs available for self-administration.
If texts in more than one language are used on primary and/or secondary packaging, such texts must be clearly distinguished.
All data printed on the cell packaging must remain available to the consumer until the last dose is withdrawn. If it is impossible to apply all the information to each cell of such a package, a method of their random application is allowed, in which they are located with the maximum frequency on the surface of the cell package. It is allowed to put the batch number and the expiration date on the edge of the blister pack. If technically possible, this information should be applied to both edges of each cell package. All information required for primary packs must be applied to each unit dose of the release form containing single-dose blister packs.

APPENDIX
to the requirements for labeling
medicines for medical
applications and veterinary
medicines

List of excipients indicated on the secondary packaging of medicinal products (veterinary drugs)

for oral administration

	The code auxiliary body substances	Threshold
Azo dyes:
sunset yellow	E110	0
azorubine (carmoisine)	E122	0
crimson (ponceau 4R, cochineal red A)	E124	0
Brilliant Black BN (Black Brilliant BN, Black PN)	E151	0
Peanut butter		0
Aspartame	E951	0
Galactose		0
Glucose (dextrose)		0
Glycerol (glycerin)		10 g/dose
Isomalt (isomaltite)	E953	0
Potassium compounds		39 mg/dose
Polyethoxylated castor oils (macrogol glyceryl ricinoleate, macrogol glyceryl hydroxystearate)		0
preservatives		0
Xylitol (xylitol)		10 g
Sesame oil		0
Lactitol (lactitol)	E966	0
Lactose		0
Latex (natural rubber)		0
Maltitol (maltitol)	E965	0

	The code auxiliary body substances	Threshold
Mannitol (mannitol)	E421	10 g
Urea		0
Sodium-containing compounds		23 mg/dose
propylene glycol and its esters		400 mg/kg for adults 200 mg/kg for children
wheat starch		0
Invert sugar		0
sucrose		0
Soybean oil		0
Sorbitol (sorbitol)	E420	0
Phenylalanine		0
Formaldehyde		0
Fructose		0
Ethanol (ethyl alcohol)		0

Percentage (v/v) in liquid dosage forms Oh.

Gubin M. M.,
Gene. director of VIPS-MED,
cand. tech. Sciences

I Introduction

The hermetic sealing operation in the manufacturing process of medicinal products (MP) plays a key role, especially in the manufacture of sterile dosage forms (DF). High-quality capping ensures the safety of the medicinal product during its transportation, storage and use by consumers. It should be noted right away that there is a primary packaging, i.e. packaging in which the drug is directly placed, as well as secondary or outer packaging, i.e. cardboard or plastic boxes, boxes, flights, which provide ease of storage, transportation and use. The quality of the primary packaging is of fundamental importance for the medicinal product, which will be the focus of this article.

II. Packing Requirements

Modern LPs are distinguished by a huge number of various options and forms of packaging. Despite this diversity, it is possible to formulate the basic requirements that must be met regardless of the form of packaging used.

These requirements can be divided into four types:

Design requirements for primary packaging.
material requirements.
Specific requirements depending on the type of product, packaging design and manufacturing technology.
General requirements to the packaging.

1. The design of the primary packaging should ensure:

protection of LP from the effects of adverse environmental influences;
protect from mechanical influences;
ensure tightness and stability;
protection against microbial contamination;
dosed or piece extraction of medicinal product;
aesthetic appearance and ease of use;
structural elements must be standardized, there should be no deviations from the geometric dimensions;
elements of the primary packaging must be designed with the possibility of their automatic processing and hermetic connection on automatic equipment.

2. Primary packaging materials must not contain:

heavy metals, arsenic, other harmful impurities, in quantities exceeding the standards;
dyes not allowed for use;
carcinogenic and toxic components;
foreign smell;
microbial contamination is higher than the established norms;

Not allowed:

damage to protective coatings;
the presence of mechanical impurities;
materials should not be brittle and must withstand heat and mechanical treatment, treatment with disinfectant solutions;
materials must be neutral and not interact with the components of the medicinal product.

3. Specific packaging requirements are determined mainly by the type of medicinal product and the technological process of its manufacture. For example, when storing a number of preparations, exposure to direct sunlight is not allowed, so the packaging must be opaque or, for example, for glass vials, made of orange glass. For injection solutions eye drops On the contrary, the packaging should be as transparent as possible to control micro-contamination.

4. General packaging requirements:

clarity of texts printed on the packaging;
a brief annotation or instructions for use;
color design;
lack of aids for opening the package;
if possible, the presence of control of the first opening;
safe handling, no sharp corners or edges.

III. Additional requirements for closures when used in automatic machines

Most of the requirements listed above are obvious and, as a rule, are met in modern packaging. However, in connection with the transfer of production to GMP compliance, a number of specific conditions arise that must be taken into account when designing or choosing primary packaging. One of the main and fundamental requirements of GMP is the maximum reproducibility and repeatability of processes, as well as the minimum participation of a person in these processes. This means that all pharmaceutical production processes should be automated.

Packaging plays a key role in the automation of drug production. As mentioned above, all packaging elements must be standardized, have no deviations from the specified dimensions, and be processed in automatic lines. This means that the packaging elements must be automatically oriented in a certain unique way and connected together automatically.

As a rule, in the manufacture of LP, the main problem is the orientation and connection of the closure elements, i.e. droppers, caps, stoppers, caps, etc.

A classic example of an optimal vial-cork-cap design, standardized throughout the world, is a penicillin vial with a neck diameter of D=20 mm, a rubber stopper and an aluminum cap. They are well oriented and processed automatically, the connection is tight and reliable. Now, with the development of the drug market, plastic packaging is increasingly used, especially for eye and nasal drugs and for non-sterile drugs. There are no standards for packaging elements for plastic, so LP developers tend to use their own packaging designs. At the same time, the possibility of their automatic orientation and feeding is often not taken into account.

Consider the main criteria that should be used when choosing packaging elements using the example of a dropper and a cap; Fig.1a, b.

To ensure non-stop operation of the automatic machine, the capping elements must:

a) easy to navigate, i.e. to be located in the bunker in a strictly defined, single position,

b) it is easy to move along the guides in the hopper and along the conveyor to the capping point,

c) easy to insert and / or twist on the neck of the vial.

Rice. 1. Packing elements: dropper (a); cover (b); metal cap (c); rubber stopper (g).

In order to provide a certain orientation in the case of an elongated design, such as a dripper (Fig.1a), it is necessary that the center of gravity is pronounced (D) and offset with respect to the dripper shoulder (F), i.e. Lv? 0.8 Ln. In this case, the fulcrum of the dripper will always be the dripper shoulder (F) and the dripper extension (B). To facilitate the orientation of the dropper, it is desirable that d 1< d 2 .

To ensure efficient feeding, the elements must have a smooth surface without roughness and rounded shapes.

When feeding lids, caps, another problem arises - they can fit into each other and collect several pieces, while it is very difficult to separate them. To avoid this, the lid should not be cone-shaped. For lids having a stepped shape (the most common), the following conditions must be met: d 2 ? 0.8d3,d1? 0.8d2.

This means that the larger diameter d 1 in principle cannot enter the inner hole with the diameter d 3 , while the smallest diameter d 2 easily exits d 3 (does not jam).

For the same reason, the lid should not be in the shape of a cone, because. the cone easily enters the internal threaded hole and jamming can occur, which is very difficult to eliminate automatically. Several elements are assembled in chains, and the equipment stops. This rule is also very important to observe for metal caps, Dн > Dв, where Dн is the outer diameter of the cap, Dв is the inner one.

Until recently, this condition was not taken into account. On the contrary, some manufacturers of caps make them with a small taper, which greatly simplifies the stamping process, but leads to constant malfunctions of automatic equipment.

Finally, the last stage of the process is the installation or dressing of the dropper, cap, cap on the bottle. Here, too, must be observed certain rules when designing closures.

Stoppers and droppers should easily and accurately enter the inside of the bottle, for this:

a) they must have a chamfer or rounding (Fig.1a, d; chamfer C) in the part that enters the vial. Its length must satisfy the conditions Lk< 0,3Lв;

b) the rest of the surface must be strictly smooth, cylindrical, without roughness. It is also very important condition. If the surface entering the inside of the bottle is cone-shaped, then there are big problems when putting on the cork, it cannot be tightly installed on the bottle. An example of an unsuccessful design is the 4C rubber stopper, which was developed in the Soviet era, without taking into account the possibility of automatic processing. Her inner part has the shape of a cone. At present, we have developed a special 4C capping method using expensive manipulators. Stoppers made in accordance with Western standards do not have such problems.

If we consider plastic bottles from the point of view of their processing in automatic machines, then the main requirement for them is to ensure the rigidity of the bottle design. If the vial does not have sufficient rigidity, it can “jump” during sorting and orientation, when feeding on automatic lines and when fitting closures on it. This usually happens with enough effort.

IV. The main types of vials, containers and closures

The manufacture of vials and containers for liquid and bulk drugs is mainly made of glass, usually for sterile drugs and plastic, mainly polyethylene, polystyrene, polypropylene, etc.

According to the methods of capping and the materials used for these purposes, they can be divided into the following groups:

1. Glass (rarely plastic) bottle with a smooth neck, a rubber stopper and a metal cap; Fig.2. This type of packaging is mainly used for the production of sterile drugs that are administered intravenously or intramuscularly. At the same time, after the selection of the medicinal product from the vial through the cork, the tightness and sterility are not violated.

Rice. 2. Packaging elements for the production of sterile drugs.

2. Plastic (or glass) bottle with a screw neck, dropper cap, plastic cap (usually with first opening control); Rice. 3. Most often, this type of packaging is used for sterile nasal, eye drops, where an accurate dosage is required, while during the first opening, the sterility of the drug is violated. For non-sterile drugs, there is another way of hermetic packaging, more often used for sealing loose substances or tablets. This method uses a combined metal-plastic membrane, which is welded (welded) onto the neck of the vial (jar).

Rice. 3. Packaging elements for sterile and non-sterile drugs for nasal and oral administration.

3. Glass or plastic bottle with a screw neck and a metal cap with a sealing gasket; Rice. 4. Usually used in the production of non-sterile preparations: tinctures, medical nutrition, syrups, etc.

Rice. 4. Packaging for non-sterile liquid drugs.

4. Sterile containers with drugs, which are sealed and sealed during the manufacturing process of drugs; Rice. 5. For glass, these are ampoules, for plastic, containers with drugs, which are often manufactured in the same technological cycle with dosing and sealing of drugs (bottelpack technology). The author and leader of this technology is the German company Rommelag.

Rice. 5. Packing of sterile drugs produced using the “bottelpack” technology.

5. Packing of drugs in the form of sprays or aerosols; Rice. 6. A glass or plastic bottle is used with a mechanical microdoser in the case of a spray and with a valve-spray head in the case of an aerosol. At the same time, for the output of various LPs, different types nozzles.

Rice. 6. Packing elements for drugs in the form of sprays and aerosols.

In conclusion, it remains to be noted that when choosing or developing modern packaging, along with traditional requirements for materials, construction, design, etc. it is necessary to take into account the possibility of automated processing of all packaging elements. Of course, this article gives only some of the fundamental points that you should pay attention to.

In practice, in each case, already at the stage of development or selection of packaging, it is necessary to consult with the developers of packaging equipment. This is especially true now - at the stage of transition of Russian pharmaceutical enterprises to technologies and production that meet GMP requirements, where the main and fundamental requirements are the reproducibility and repeatability of technology, which can only be ensured by using automatic machines.

Bibliography

OST 64-803-01. Transport, group and consumer packaging for medicines
V.F. Stolepin, L.L. Gurary. "Starting materials for the production of medicines". M.: Medical Information Agency, 2003
"Pharmaceutical technology: technology of dosage forms", I.I. Krasnyuk and others. M .: Publishing Center "Academy", 2006
MM. Gubin "The main problems in the development and manufacture of packaging elements associated with their use in automatic packaging machines."
Seminar "School of Pharmaceutical Packaging 2005" - Abstracts of the report, 2005, St. Petersburg, p. 13.

INTRODUCTION .................................................. ................................................. .3

CHAPTER 1

1.1 Types and functions of drug packages ............................................................... .............................5

1.2 Basic requirements for the packaging of medicinal products .............................................. ................ten

CHAPTER 2. ANALYSIS OF CONSUMER PREFERENCES .................................14

2.1 Influence of packaging on consumer preferences....................................................14

2.1 Determination of consumer preferences in relation to medicines and their packaging .............................................................. ....................17

CONCLUSION................................................. ................................................. ..23

BIBLIOGRAPHY................................................ ................................................25

APPLICATIONS.................................................. ................................................. ..27

INTRODUCTION

Relevance of the topic. With the development of a market economy, the efficiency of domestic enterprises largely depends on whether their products are successful in the market. Therefore, more and more often there is a need to investigate the state of consumer preferences in relation to a particular product. Consumers during the acquisition or use of goods, including medicines, to meet their needs, have the right to safety and proper quality of goods, to state protection of their rights and compensation for losses caused by goods of inadequate quality. Awareness of this information poses a challenge for pharmaceutical companies to conduct more in-depth scientific research in this direction.

Production of pharmaceutical packaging is an integral part pharmaceutical industry. Packaging has become a very important part of drug production as it innovation in the development of new drugs and new systems for delivering drugs to the body has reached a very high level. Pharmaceutical packaging must meet the increasing requirements for medicines.

Due to the unique requirements for pharmaceutical products, packaging for medicines must guarantee the preservation of the quality of medicines during transportation, which will increase their shelf life.

Objective- to study the features of modern packaging of medicines.

To achieve the goal, it is necessary to solve the following tasks:

1. To study the types and functions of drug packages;

2. Consider the basic requirements for the packaging of medicines;

3. Analyze and find out the impact of packaging on consumer preferences.

Object of study. Packaging and registration of medicines.

Subject of study. Requirements for the quality of packaging of medicinal products.

Research hypothesis. The material and appearance of drug packaging containers influence the preferences of buyers.

Work structure. Course work consists of an introduction, two chapters, a conclusion, a bibliography and an appendix.

CHAPTER 1. MODERN APPROACHES TO PACKAGING OF MEDICINES

Types and functions of drug packages

Packaging is understood as a complex consisting of containers, auxiliary means, packaging materials that determine the consumer and technological properties of the packaged product.

There are two types of drug packaging: primary packaging (individual) and secondary packaging (group or consumer).

Primary packaging- direct (individual) packaging, which contributes to the preservation of the goods during its sale; is part of the goods and, in general, is not subject to self-transportation;

secondary packaging- serves to protect individual packaging and surpasses it in terms of information content; performs protective function in relation to the product and primary packaging and creates conditions for their immunity to outside influences.

Primary packaging, depending on the materials used, their mechanical stability and strength, which determine the degree of preservation of goods, is divided into groups and types. For various dosage forms, GOST defines the types of primary packaging and closure material.

There are the following types of primary packaging for medicines (according to GOST 17768-90) (Appendix 1).

By material: hard, semi-hard, soft.

Rigid packing:

Metal is used for primary packaging: jars, test tubes (for packing tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments);

Glass is used for the production of jars, test tubes, vials, bottles (they pack tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops), ampoules;

The polymer is used to make test tubes, cups, jars (they are used to pack tablets, dragees).

Semi-rigid packaging:

Cardboard is used for the production of boxes, packs (for plasters, herbal medicines);

Polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used to pack eye drops; contours used for packaging suppositories;

The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, herbal medicines.

Soft packing:

From polymer it is used as packaging in the form of bags for powders, granules, plasters;

Paper packaging in the form of a bag, wrappers is used for packaging dragees, tablets, herbal medicines.

All types of primary packaging and closures for it should be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial articles.

Materials used for the manufacture of primary containers and closures must be approved for use by the Ministry of Health Russian Federation.

Main types secondary packaging used for medicines:

Cardboard is used to produce packs for jars, test tubes, vials with medicines for injection, bottles, aerosol cans, ampoules; boxes are used for packing ampoules, vials, syringe tubes;

Polymers are used to make contour packaging for ampoules, vials with medicines for injection, and syringe tubes.

When packing ampoules, it is allowed to use medical alignin as a shock absorber. An ampoule opener must be included in each package of ampoules.

By appointment packaging is divided into: consumer, group and transport.

Consumer packaging with medicinal products must be packed in a group container - carton boxes or foot, followed by packing the foot in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes may be packed in shrink film. If the medicinal product does not have a secondary packaging, then instructions for use (or leaflets) should be enclosed in the group packaging in the amount equal to the number primary packages. The dimensions of the container must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container).

Group packaging with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, sack paper. Each packing unit of any type of group container is supplied with a label. For tying group containers, materials are used that ensure the strength of the package. When gluing or tying group containers, the ends are sealed with a label that provides control of opening.

To transport packaging medicines include wooden, polymeric and cardboard boxes. Inner surface plank crates or crates made of wood-based panels are lined with wrapping paper, parchment, wrapping paper or plastic wrap. When packaging the medicinal product, the free space in the boxes is filled with soft packaging material, which excludes their movement. It is allowed to use packaging alignin as a sealing material; paper and cardboard waste paper; shavings from porous elastic polymeric materials. The gross weight of the package must not exceed 20 kg.

Liquid and viscous medicinal products require the use of packages that provide an accurate dose measurement. Basically, glass containers are used, for example: jars and bottles made of glass with a screw neck, oval jars and bottles with ground stoppers, jars and bottles made of dart, etc.

Medical ointments at present, they are produced mainly in aluminum tubes and glass containers (they use glass jars with a low screw neck, jars made of drota). Aluminum tubes are made in two versions: regular and with an elongated spout. The inner surface of the tubes is covered with a protective layer of lacquer, and the outer surface is covered with a decorative resistant enamel, which is marked. The serial number is embossed on the tail of the tube when it is sealed.

Solid dosage forms. Tablets account for approximately 70% of the total output of finished drugs, and their production tends to increase. Tablets are packaged in a variety of containers, including paper (non-currency), glass (jars and bottles), metal (test tubes, pencil cases), etc. The most promising is blister packaging (blisters).

Dosed packages powders are equipped with different design devices for dosed issuance. They are mainly produced by foreign companies and represent a two-chamber system consisting of an external closed chamber communicating with the cavity of the container in which the drug is placed, and an internal dosing chamber.

Injection solutions most often packaged in ampoules, which are disposable packages, i.e. disposable packaging.

The glass ampoule is an ideal packaging in terms of its compatibility with pharmaceutical products, tightness and cost. However, at the same time, the fragility of glass is a serious drawback, so expensive secondary packaging is needed to prevent breakage, depressurization of ampoules, and cracking. In recent years, ampoules made of polymeric materials have been used, but there are problems associated with the compatibility of plastics with a solution of a medicinal substance and the shelf life of these ampoules.

Some special types of packages. For unstable drugs that lose activity in solutions or require preparation immediately before use, packages are being developed for separate storage of components. These are combination packs having two separate chambers with medicinal substances ready to be mixed at the time of consumption (expensive but necessary packaging).

Medicine packaging technology In pharmaceutical production, containers and packaging play a special role, providing not only the possibility of convenient use of medicines, but also the preservation of their properties during storage. The problem of packaging finished medicines requires constant attention, because. its irrational choice leads to a decrease in quality and significant losses of medicines and packaging materials.

Basic concepts of containers and packaging Packaging is a set of tools designed to protect the drug from the effects of environment, damage and loss and facilitating the handling process. A container is an element of packaging and is a container designed to accommodate products. Packaging combines containers, medicines, closures and auxiliary elements that determine the consumer properties of the product. For example, an empty bottle is a container, and a bottle with a drug, a stopper or a dropper, a label or other auxiliary means is a package. In the production of FPP, packaging is classified into the following types: Primary packaging Individual or consumer packaging, the material of which is in direct contact with the drug. It is designed to create the necessary conditions to ensure the long-term preservation of the LF contained in it. Secondary packaging is a package designed to protect the integrity of primary packages and to provide more complete informative information (for example, about methods of administration and doses of drugs).

Secondary packaging provides the most simple and convenient accounting and product control. As secondary packaging, cardboard packs and boxes are used, where tablets, dragees, capsules, vials and ampoules with liquid and powdered drugs, metal and polymer test tubes with tablets, tubes with ointments, bags with powdered drugs are placed in the primary blister pack. In some cases, secondary packaging creates additional sealing and protection of primary packaging from the influence of external factors. Secondary packages also belong to consumer ones, so it is important to ensure the necessary consumer properties of the package, such as: ease of wearing, information on the storage and use of the product, control of the first opening of the package, maintaining microbiological purity and attractive appearance. Group packaging (or block) is a group of primary or secondary packaging, which is formed when packaging products in shrink film, paper, cardboard boxes. Transport packaging packaging in a shipping container in which products are delivered to distribution and sale sites. It can be the same for each series of drugs.

Materials and methods of packaging manufacturing The container material approved for use in the pharmaceutical industry is subject to special requirements: gas and vapor impermeability, chemical indifference to drugs, resistance to temperature effects, strength, light impermeability, barrier resistance to microorganisms, ensuring maximum shelf life. There are the following types of primary packaging for medicines (according to GOST) Rigid packaging 1. metal is used for primary packaging: jars, test tubes (for packaging tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments ); 2. glass is used for the production of jars, test tubes, vials, bottles (they pack tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops), ampoules; 3. the polymer is used for the manufacture of test tubes, cups, jars (they are used for packaging tablets, dragees).

Semi-rigid packaging: 1. cardboard is used for the production of boxes, packs (for plasters, herbal medicines); 2. polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used to pack eye drops; contours used for packaging suppositories; 3. The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, herbal medicines. Soft packaging: 1. made of polymer is used as packaging in the form of bags for powders, granules, plasters; 2. paper packaging in the form of a bag, wrappers is used for packing dragees, tablets, herbal medicines. All types of primary packaging and closures for it should be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial articles. The materials used for the manufacture of primary packaging and closures must be approved for use by the Ministry of Health of the Russian Federation.

Packaging should be the same for each series of packaged medicinal products and take into account their physiochemical properties 1. Light-sensitive medicinal products are packed in light-tight containers; 2. medicines containing volatile, weathering, hygroscopic or oxidizing substances are packed in jars or vials sealed with screw caps complete with stoppers or gaskets with sealing elements; plugs with sealing elements; rolled-in metal caps complete with plugs or gaskets with sealing elements, rolled-in metal caps; 3. Medicinal products containing highly volatile, weathering, hygroscopic and oxidizing substances intended for export are packed in containers sealed with roll-top lids or in other containers that ensure their safety; 4. each medicinal product containing a volatile substance or having an odor is packed separately from the others; 5. tablet medicines containing essential oils, wrapped in paraffin paper before packing into test tubes; 6. shock absorber seals when packing tablets, dragees or capsules in a container that does not have a stopper with shock absorbers. It is allowed to use medical absorbent cotton wool or carded viscose tape. Secondary packaging is designed to protect the inner packaging and promote sales.

The main types of secondary packaging used for medicines: 1. Cardboard is used to produce packs for jars, test tubes, vials with medicines for injection, bottles, aerosol cans, ampoules; boxes are used for packing ampoules, vials, syringe tubes; 2. Polymers are used to make contour packaging for ampoules, drug vials for injections, and syringe tubes. When packing ampoules, it is allowed to use medical lignin as a shock absorber. Each package with ampoules must contain a device for opening ampoules. Consumer containers with medicinal products should be packed in group containers, cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes may be packed in shrink film. If the medicinal product does not have a secondary package, then instructions for use (or leaflets) should be enclosed in the group package in an amount equal to the number of primary packages. The dimensions of the container must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container). Group containers with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, sack paper. Each packing unit of any type of group container is supplied with a label. For tying group containers, materials are used that ensure the strength of the package. When gluing or tying group containers, the ends are sealed with a label that provides control of opening.

Group and transport packaging is used for transportation, warehousing, storage of goods and wholesale or small wholesale sales. It provides protection of the goods from mechanical impacts that may occur as a result of squeezing, bending, twisting, stretching, etc., and losses during transportation and storage. The transport packaging of medicines includes wooden, polymeric and cardboard boxes. The inner surface of board boxes or boxes made of wood-based materials is lined with wrapping paper, parchment, wrapping paper or polyethylene film. When packaging the medicinal product, the free space in the boxes is filled with soft packaging material, which excludes their movement. It is allowed to use packaging alignin as a sealing material; paper and cardboard waste paper; shavings from porous elastic polymeric materials. The gross weight of the package must not exceed 20 kg.

secondary packaging- antrinė pakuotė statusas Aprobuotas sritis veterinariniai vaistai apibrėžtis Pakuotė, į kurią įdėta pirminė pakuotė. atitikmenys: engl. outer packaging vok. äussere Umhüllung, f rus. secondary packaging pranc. emballage exterior isp. embalaje… …

secondary packaging- 3.6. secondary packaging: A packaging container (envelope, box) in which an electronic document carrier is placed in primary packaging. Other terms: According to GOST 7.4, GOST 7.9, GOST 7.60. Source …

Secondary packaging of the electronic edition- a packaging container (envelope, box) in which the electron carrier is placed. publications in primary packaging. On V. at. GOST 7.83 2001 requires the following elements of output information to be placed: mandatory a) information about the authors and other physical. and legal ... ... Publishing Dictionary

Group (secondary) packaging- Group packaging, or secondary packaging, packaging containing a certain number of units of goods and approved for sale in point of sale to the end user or consumer or serving to replenish inventory (shelving). At… … Official terminology

secondary packaging- A container or other form of packaging in which the medicinal product is placed in the primary packaging. [MU 64 01 001 2002] Subjects production of medicines Generalizing terms container and packaging of medicines ... Technical Translator's Handbook

recycling of packaging waste into raw materials- 3.4 recycling of packaging waste into raw materials: Recycling of packaging waste, during which materials (fractions of packaging waste, used packaging) of usually organic origin are converted into products with ... ... Dictionary-reference book of terms of normative and technical documentation

International symbol for recycling. Recycling (other terms: recycling, recycling (waste) (from English recycling, recycling and waste disposal) reuse or recycling of waste ... ... Wikipedia

GOST R 53756-2009: Resource saving. Package. Criteria for selecting methods and processes for processing used packaging as secondary material resources, taking into account material flows- Terminology GOST R 53756 2009: Resource saving. Package. Criteria for choosing methods and processes for recycling used packaging as secondary material resources, taking into account material flows original document: 3.7 recovery ... ... Dictionary-reference book of terms of normative and technical documentation

GOST 7.83-2001: System of standards for information, librarianship and publishing. Electronic publications. Main views and output information- Terminology GOST 7.83 2001: System of standards for information, librarianship and publishing. Electronic publications. Main types and imprint of the original document: 3.6. secondary packaging: Packaging container (envelope, box), in ... ... Dictionary-reference book of terms of normative and technical documentation

- (Gyno Kit) Syndromic treatment of abnormal vaginal discharge and STIs such as gonorrhea, chlamydial infections, bacterial vaginosis, trichomoniasis and vulvo vaginal candidiasis. Trade name Gino Kit International ... ... Wikipedia

antrine pakuotė- statusas Aprobuotas sritis veterinariniai vaistai apibrėžtis Pakuotė, į kurią įdėta pirminė pakuotė. atitikmenys: engl. outer packaging vok. äussere Umhüllung, f rus. secondary packaging pranc. emballage exterior isp. embalaje exterior it.… … Lithuanian dictionary (lietuvių žodynas)