Since February 1 of this year, an experiment from Roszdravnadzor on the labeling of medicines was conducted in 6 regions of Russia. This event was attended only by pharmaceutical companies that have expressed their voluntary consent to the program. During this experiment, monitoring was carried out, as well as the evaluation of various methods for tracking and determining the quality of drugs. According to the data obtained, it was possible to draw up certain requirements and standards governing the activities during which the circulation of medicinal products is carried out.
Based on this, the labeling of medicines from 2018 (or rather, during the year) will become mandatory. At the same time, new requirements will be introduced in stages.
What is it for
Thanks to new regulations, it is planned to get rid of counterfeit and counterfeit products. And it’s not a secret for anyone that today such drugs occupy a predominant part of the market. Because of this, the population receives poor-quality and inactive treatment.
Due to the obligatory labeling of medicines and informing citizens about the main provisions of the new law, it will be possible to count on a higher level of quality of medicines sold in pharmacies.
Previously, there was no single scheme for creating packaging, compiling annotations and warnings on medicines. Accordingly, there were many types of counterfeit products. Thanks to the new rules, all labels and inserts on medicines will have to contain a single list of information submitted in a single form, which is described in regulatory documents.
Due to the general form of drug labeling, it will be much easier to track and control the production of this type of product. Consider the main points of the new legislation.
Basic concepts
First of all, speaking about the law on the labeling of medicines, it is worth clarifying the main definitions. Namely, we are talking about:
- "Secondary packaging." In this case, this refers to the packaging material in which the drug previously prepared for sale is placed. In simple terms, the secondary packaging is the box itself with the drug.
- "Labeling". Represents textual information that is applied directly to a box (secondary packaging) with a drug (or veterinary drug).
- "Primary packaging." In this case, we are talking about packaging material that comes in contact with the medicine itself. For example, if you buy tincture of valerian in a pharmacy, then the box itself will be the secondary packaging, and the bottle in which the liquid is located will be the primary one.
- "Intermediate packaging." In some situations, an additional composition is placed between the primary and secondary packaging material, which prevents damage to the drug vessel.
- "Packaging". In this case, this or that material is meant or a kind of design that will guarantee the safety of the drug throughout the stated storage period. In this case, the package must reliably protect the composition from possible damage or the negative effects of the environment.
Also in the decree on the labeling of medicines the concept of "cell contour packaging" is indicated. In this case, it is also appropriate to use the concept of a blister. It is a flexible packaging material equipped with special cells from which tablets or capsules are extruded.
Speaking about the drug labeling system, it is worth highlighting several key points that are worth paying attention to.
Types of medicines
First of all, the name of the drug or veterinary drug should be indicated in the nominative case.
If we are talking about herbal remedies, then in this case it is necessary to additionally indicate the name of a particular herbal composition in the name of the drug. In this case, the substance fits exclusively in Latin (unless it is a drug collection) in the plural. The only exceptions are the words “bark” and “grass”.
If we talk about the types of packaged products, it is allowed to enter “powder”, “whole”, “crushed”, etc. In addition, the labeling of medicines should be easy to read and understand by consumers. This means that the name of the drug and information about it cannot be written in small, almost imperceptible font.
If the preparation contains generic substances, then they should also be indicated in the nominative case. At the same time, both Russian and English are allowed. However, transliteration should be consistent with the name on the WHO registry.
INN can not be indicated only if it fully coincides with the name of the trade name of the drug.
If we are talking about a heterological agent, then in this case, according to the requirements for the labeling of drugs, it is necessary to indicate the type of animal whose blood or plasma was used in the production of the composition.
When selling medicines of biological origin, INN is sometimes absent. In this case, the packaging should indicate the source of the sold composition.
If we are talking about drugs of the radiopharmaceutical type, then a symbol is applied to the label indicating the chemical composition of the component. Additionally, the radionuclide index and the symbol indicating that the composition is radioactive are indicated.
How the holder should be indicated
This refers to the owner of the registration document, that is, the manufacturer of a particular drug. In this case, the holder also fits in the nominative case. However, it is not uncommon for several manufacturers to take part in the production of the composition. In this case, the holder who was responsible for product quality control should be indicated.
If the names of two owners of registration documents coincide, then there is no need to enter them twice.
Dosage and volume
We are talking about the activity and concentration of the active pharmaceutical substance in the composition of the drug. In this case, the mandatory labeling of medicines implies an indispensable indication of generally accepted units of measurement.
The concentration of the composition is determined by its weight, volume or number of dosage units. Moreover, this indicator may vary based on the form of release of the drug and the type of packaging material.
If we are talking about drugs, which are packaged raw materials of plant origin, then in this case, the humidity of the substance must be taken into account. When indicating the activity of such drugs, it all depends on the requirements for medical use, as well as on general data characterizing the composition, which are compiled and approved by a special commission.
Instruction manual
The new bill on the labeling of medicines contains information regarding the annotation accompanying the preparations of the medicinal group. In accordance with the requirements for the receipt of such goods in circulation, the instructions must indicate data on:
- Manufacturer (not only the name of the company, but also its legal address).
- Side effects. At the same time, all possible undesirable effects are listed, regardless of how low the probability of their manifestation.
- The name of the drug according to international nomenclature requirements.
- The main and minor components that make up the composition. Moreover, regardless of the amount of different substances, all of them should be listed. The patient must be sure that the medicine does not even have the minimum content of the component to which he has an allergic reaction.
- The scope of the drug. In this case, we are talking about diseases in which the drug is indicated for use. Also listed are the symptoms in the fight against which this tool will be most effective.
- Dosage and method of use. Some drugs are taken orally, others are only allowed to be injected into the body.
- All contraindications and possible painful conditions in which the use of this drug is not recommended or even prohibited.
- Expiration date.
- Interactions with other drugs or individual components. Also, this paragraph necessarily describes the possible consequences when using several categories of compounds.
Among other things, the requirements for labeling medicines indicate that the annotation must necessarily contain information with instructions not to use this drug after its expiration date. This is due to the fact that today the cost of medicines is too high, which is why some people neglect these recommendations. It can be very life threatening.
Composition
In this list, it is necessary to indicate not only the name of the components, but also their volume included in a particular drug. The same goes for auxiliary components. However, they are not always indicated on the main packaging material.
If the drug is recommended for oral administration, the composition should be indicated on the secondary packaging. At the same time, the volume of all components should also be written on it.
If the drug is intended for injection, then on the secondary packaging it is enough to indicate only the full composition. The volume fraction of the individual components is optional.
When selling drugs for inhalation, according to the requirements for labeling drugs, the box also indicates the component composition without volume. The same applies to external or local use, as well as drugs that are used in ophthalmology.
If we are talking about infusion solutions, then complete information about the composition is indicated on both the secondary and primary packaging.
Two component formulations
Speaking about what, starting in 2018, the packaging and labeling of medicines should be, it is worth paying attention to medicines in this category. If the preparation is a kit consisting of an active substance and an activator, then in this case two or three production dates must be indicated on the secondary packaging. The former are responsible for the production of components. The third date indicates the release of the entire set. If we talk about the expiration date, then in this case it can be only one, so as not to confuse buyers. The total date after which the drug cannot be used is determined by the freshness of the component that has deteriorated earlier.
If herbal medicinal preparations are packaged, then water extracts of the raw materials are made, according to which the total shelf life of such compounds is determined.
Speaking about two-component compositions, it is also worth considering the instructions for the use of such kits. These data are indicated based on the general characteristics of the medicinal formulations, as well as based on annotations and recommendations for the use of the drug.
If the method of introducing the drug into the human body is indicated in the product name itself, then you do not need to write it separately on the package.
Requirements for marking methods
In this matter, it is worth paying attention to the fact that the shade of the text itself, as well as related symbols and signs should be quite contrasting. The background should be much brighter than the inscriptions. Thus, it will be much easier for the buyer to get acquainted with the information he is interested in.
In this case, it is necessary to carry out thorough checks of equipment for labeling drugs. The fact is that, according to the requirements, the safety of the inscriptions on the package must be ensured throughout the shelf life of the composition. If after a few months the name of the drug fades, then the person will not be able to correctly determine what exactly he is going to take.
The batch number, production date and expiration dates can be stamped. In this case, the characters will be the same color as the background itself. This method allows you to ensure the safety of the inscriptions.
Font
In addition, the new law provides recommendations for the size of characters. The text must be at least 7 points in size. In this case, the distance between horizontal rows can be at least 3 mm. It is also worth avoiding monograms and other embellishments of the font, as they greatly reduce the readability of characters.