Types of packages. Packing and packaging of finished medicines Primary and secondary consumer packaging

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 sets the task for pharmaceutical enterprises to conduct more in-depth scientific research in this direction.

Production of pharmaceutical packaging is an integral part of the 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. The course work consists of an introduction, two chapters, a conclusion, a list of references 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 a 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.

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.

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 should be packed in a group container - 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 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.

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.

To transport packaging medicines include 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.

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).

Packaging plays an important role in the production and distribution of medicines. It must fully comply with all regulatory requirements for this type of product. Pharmaceutical packaging falls into three main categories:

Primary packaging

Primary is in direct contact with the medicinal product and is designed to create conditions that will ensure long-term preservation of products. It includes: glass ampoules, vials, jars and bottles, polymer containers, aerosol cans, blisters, capsules, aluminum tubes, syringes and more.

secondary packaging

It does not come into direct contact with the drug and is designed to protect and preserve the primary packaging, as well as to account for and control stored products. There are certain requirements for packaging for medicines:

• legibility of information printed on it;
• brief instructions for use;
• safe handling;
• control of the first opening (if possible);
• lack of aids for opening.

For the manufacture of secondary packaging, various materials are used:

• Cardboard. Packs and boxes are made from it, in which blisters with tablets, capsules, aerosol cans, vials, bottles, polymer containers and so on are packed.
• Polymers. They are used for the manufacture of contour packaging for ampoules, vials, syringe tubes. In most cases, the medicine is already in polymer packaging, everything is packed in cardboard.
• Shrink. It packs jars, vials, bottles. Often in this form, drugs are transported.

Another important function secondary packaging performs is to provide useful information about the contents of the box. On the pharmaceutical packaging indicate the name, concentration of the active substance, the number of tablets or capsules, the warranty (limit) period of use. This information is placed on at least two opposite sides of the box. It is also very important to note that if the primary packaging needs to be opened using any means, then they must be included in the medicine box.

Tertiary packaging

Tertiary or transport packaging is designed to deliver products to the point of sale. The main task of transport packaging is to protect medicines from external physical influences and mechanical damage. As a tertiary container, wooden boxes, containers, as well as bags can be used: fabric, paper and polymer materials. Very often, for long-distance transportation, boxes and boxes are placed on pallets, wrapped with stretch film or glued with adhesive tape, which allows both to optimize the loading process and additionally protect medicines from mechanical influences.

Requirements for transport packaging:

• safety - is the absence of contamination of products with packaging components, including those harmful to humans;
• reliability - the safety of drugs in the proper form for a long time;
• environmental friendliness - the possibility of recycling after use;
• interchangeability - the possibility of replacement, while not changing the functional purpose;
• The aesthetic appeal of the packaging also plays an important role.

If you need quality pharmaceutical packaging, then you should take this very seriously, because not every company can fulfill the high requirements that apply to such products.

1. Medicinal products, with the exception of medicinal products manufactured by pharmacy organizations, veterinary pharmacy organizations, individual entrepreneurs who have a license for pharmaceutical activities, must enter circulation if:

1) on their primary packaging (with the exception of the primary packaging of herbal medicinal products), the name of the medicinal product (international non-proprietary, or grouping, or chemical, or trade name), batch number, release date (for immunobiological medicinal products) are indicated in a well-readable font in Russian ), expiration date, dosage or concentration, volume, activity in units of action or number of doses;

2) on their secondary (consumer) packaging, in a well-readable font in Russian, the name of the medicinal product (international non-proprietary, or grouping, or chemical and trade names), the name of the manufacturer of the medicinal product, batch number, release date (for immunobiological medicinal products), registration certificate number, expiration date, method of administration, dosage or concentration, volume, activity in units of action or number of doses in a package, dosage form, dispensing conditions, storage conditions, warning labels.

(see text in previous edition)

2. Pharmaceutical substances should be put into circulation if their primary packaging in a well-readable font in Russian indicates the name of the pharmaceutical substance (international non-proprietary, or grouping, or chemical and trade names), the name of the manufacturer of the pharmaceutical substance, the batch number and date of manufacture, the quantity in packaging and quantity units, expiration date and storage conditions.

(see text in previous edition)

3. Medicinal products as sera must be put into circulation with an indication of the animal from whose blood, blood plasma, organs and tissues they are obtained.

4. On the secondary (consumer) packaging of medicinal products obtained from blood, blood plasma, human organs and tissues, the inscription should be applied: "Antibodies to HIV-1, HIV-2, to the hepatitis C virus and the surface antigen of the hepatitis B virus are absent" .

5. A radiation hazard sign must be applied to the primary packaging and secondary (consumer) packaging of radiopharmaceuticals.

6. The inscription "Homeopathic" must be applied to the secondary (consumer) packaging of homeopathic medicinal products.

7. The following inscription must be applied to the secondary (consumer) packaging of medicinal herbal preparations: "The products have passed radiation control."

8. Primary packaging (if there is a technical possibility for this) and secondary (consumer) packaging of medicinal products intended for clinical trials must bear the inscription: "For clinical trials".

(see text in previous edition)

9. The packaging of medicines intended exclusively for export is labeled in accordance with the requirements of the importing country.

10. The transport container, which is not intended for consumers and in which the medicinal product is placed, must be marked with information about the name, series of the medicinal product, release date, number of secondary (consumer) packages of the medicinal product, manufacturer of the medicinal product, indicating the name and location of the manufacturer of the medicinal product. means (address, including the country and (or) place of manufacture of the medicinal product), as well as the expiration date of the medicinal product and the conditions of its storage and transportation, the necessary warning labels and handling signs.

11. Primary packaging and secondary (consumer) packaging of medicinal products for veterinary use shall bear the inscription: "For veterinary use".

12. A bar code is applied to the secondary (consumer) packaging of the medicinal product.

Contents

Labeling requirements for medicinal products for human use and veterinary medicinal products

General provisions

1. 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).
2. The 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.
3. 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).
4. 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 of the medicinal product (veterinary product);
• "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 for the purpose of additional protection of the medicinal product (veterinary drug) or based on the specifics 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 plant 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…”).

1. On the primary packaging in the form of a blister strip packaging (blister) (hereinafter referred to as the cellular packaging), which is placed in a secondary (consumer) packaging (hereinafter referred to as the secondary packaging), it is allowed not to indicate the information provided for in subparagraphs "c" and "e" of paragraph 5 of these requirements.
2. On primary packaging of small size (the 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.
3. 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;
• p) registration number (for veterinary drugs).

1. For drugs manufactured both with and without a preservative, when producing products without a preservative, the following information is indicated on the secondary packaging after the list of excipients: “Does not contain a preservative”.
2. 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.
3. 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.

1. For a set (drug (veterinary drug) with a solvent (diluent)) or set (set of 2 or more drugs (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 on the availability of auxiliary medical devices (syringes, swabs, injection devices, etc.).

1. It is not allowed to put on the package 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.

1. 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).

1. 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.

1. 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

1. 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 plant materials, the name of the medicinal plant material or active pharmaceutical ingredient of plant origin in Latin (except for the name of the fees) in the plural (except for the words "grass" and "bark") and type packaged products (for example, “whole”, “ground”, “powder”, etc.).

1. The INN of active pharmaceutical ingredients in the composition of a medicinal product (veterinary drug) is indicated in Russian in the nominative case and in English (in accordance with the English edition of the INN list of the World Health Organization).

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.

1. 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 “packed” and (or) “packed”, “packer”.

1. Addresses are indicated in abbreviated form (country or country and city) or in full, additionally it is allowed to indicate phone numbers, fax numbers, e-mail addresses.

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.

1. 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.
2. 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 that 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 the general characteristics of medicinal products for medical use, approved by the Commission.

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

1. Active pharmaceutical substances (components) and their quantity are indicated in the composition of medicinal products (veterinary drugs).
2. 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 the full composition of excipients (components) on the 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.

1. The composition of homeopathic medicinal products (veterinary drugs) 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.
2. For medicinal herbal preparations (veterinary preparations), which are packaged medicinal plant raw materials, the composition is indicated only for fees.
3. References to quality control standards for active pharmaceutical ingredients and (or) excipients are not indicated.
4. The production date may be omitted if it is included in the batch number.
5. For a kit (medicinal product (veterinary drug) with a solvent (diluent)) or kit (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).
6. 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 specified 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 set (drug (veterinary drug) with a diluent (diluent)) or set (set of 2 or more medicinal products (veterinary drugs)) on the secondary packaging, the production dates of each component or a single release date of this kit (set), 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).

1. 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.
2. The route of administration (route of administration, method of administration) is indicated in accordance with the general characteristics of this drug and the instructions for use of this veterinary drug. 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.

1. 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 medicinal products (veterinary drugs): “in / in” (intravenous administration), “ i / m "(intramuscular injection)," p / c "(subcutaneous injection).
2. 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.
3. Features of labeling of medicinal products (veterinary drugs) related to narcotic drugs, psychotropic substances and their precursors shall be established in accordance with the legislation of the Member States.
4. 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.

1. 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.

1. The labeling of a homeopathic medicinal product registered under the 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 should 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.

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

The name of the drug, dosage and, if applicable, the total content of the 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.

1. 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.
2. 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.
3. Glare-creating glossy, metallic or other packaging that impairs legibility should be avoided. It is not recommended to use different font colors 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.

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 likelihood 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.

1. 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 state programs”, etc.) without using labels (stickers).

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.

1. 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).
2. 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".

1. 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.
2. If texts in more than one language are used on primary and/or secondary packaging, such texts must be clearly distinguished.
3. 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 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

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

1. Introduction………………………………………………………….page 3

2. Types of drug packaging, their functions………….page 3-6

3. Separate types of packaging dosage forms………………page 6-8

4. Basic requirements for the packaging of medicines………………………..…page 8-9

5. Modern approaches to drug packaging…………………………page 9-10

6. Conclusion………………………………………………………..page 11

7. References……………………………………………….page 12

Introduction

Production of pharmaceutical packaging is an integral part of the 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. Packaging for pharmaceutical products and traditional packaging for other products are incomparable things. The production of pharmaceutical packaging should be based on scientific research, while traditional packaging is more consumer-oriented.

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.

Types of drug packaging, their functions

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 that 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 a 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).

Material: rigid, semi-rigid, soft.

Rigid packing:

The metal is used for primary packaging: jars, test tubes (for packaging

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.

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 must be the same for each series of packaged medicinal products and take into account their physical and chemical properties:

Medicines that are sensitive to light are packed in light-tight containers;

Medicinal products 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;

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;

Each medicinal product containing a volatile substance or having an odor is packed separately from the others;

Tableted medicines containing essential oils are wrapped in paraffin paper before being packed into test tubes; 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.

The main types of 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. Each package with ampoules must contain a device for opening ampoules.

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

Consumer packaging with medicines should be packed in a group container - 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.