Requirements for pharmaceutical activities in the Republic of Armenia
Production and distribution of medical drugs in the Republic of Armenia
The medical drug market in the RA is very dynamic and is developing rapidly. The market is consistently expanding with new players. One must note that the state regulation in the field of medicine is very important. In order not to face any legal issues, or extensive problems in the future to do with implementation and/or dissemination of medical drugs, one must first carry out a thorough analysis of the legislation of the Republic of Armenia in this area.
First let us look at the definition of ‘medical drug’. According to paragraph A, Article 1 of the RA Law “On Medicines”, a medical drug is a metered agent having biological activity which is obtained on the basis of one, or more drugs and auxiliary substances having a standard composition, is under a registered consistent name, the necessary medicinal dosage form and decoration. It is intended for the treatment, diagnosis, prevention of human and animal diseases, pain management, prevention of pregnancy, it affects the functions of the body.
Pharmaceutical activity in the RA refers to activities carried out in the sphere of production, transportation, storage, dispensing, counseling, distribution, sale, export, import and disposal of pharmaceutical products. The right to exercise pharmaceutical activity are the persons who have received higher education and/or vocational education, and who hold a special pharmaceutical license. Please note, that the implementation of pharmaceutical activity without a license is illegal and is punishable by law. Issuing licenses for pharmaceutical activities in the RA is The Ministry of Health of the Republic of Armenia.
Drug production is carried out in accordance with the rules and procedures established by The Ministry of Health of the RA. Making and/or production of medical drugs occurs in pharmacies on the basis of prescriptions and signatures issued by a licensed medical doctor. There is no doubt that an effective legal regulation of production and turnover of drugs is crucial, as this affects issues related to the health of the entire population of the Republic of Armenia. Thus, drug manufacturing process and production is subject to rigorous control by the State.
Registration of drugs:
As a general rule one is only allowed to produce the medical drugs that have passed state registration. Exceptions to the rules are the medical drugs established by the government.
Medical drugs that are subject to registration:
- New drugs and forms offered for medicinal purposes;
- Immuno-biological preparations;
- New combinations of registered drugs;
- Registered medicines that are dispensed according to the new dosage form and for proposing new ways of use and include new evidence;
- Reproduced drugs (generics), nominally equivalent to registered ones of the same brand, but manufactured by others on modified technology with other auxiliaries.
The deadline for registration of medical drugs is five years. Registration is not required for pharmacological agents and drugs manufactured in pharmacies by prescription.
Marking (labels) drugs:
Produced and manufactured medical drugs are subject to labeling that must meet certain legal requirements. The label, labeled packaging, liner and instruction on the use of drugs should contain information on drugs approved under the rules, contain warning note on dangers due to exceeding the permissible dosage and the need to keep drugs out of the reach of children.
In order for the produced medical drug(s) to enter into circulation, it is necessary that on the outer and inner packaging there is a clear visible name and address of the manufacturer, the name of the medication, date of manufacture, the method of use, weight (volume) and the amount of each unit, shelf life and storage conditions. An inscription “Sample not for sale” must be present on the experimental samples. On genetically engineered drugs it is necessarily to note active substances and modified microorganisms applied during manufacture. The raw material from which the medical drug(s) have been manufactured must not contain radioactive substances and it shall bear the inscription: “The products have passed radiation control.” On homeopathic medical drug(s) should be an inscription indicating “Homeopathic”.
Information about advertising pharmaceutical drug(s):
Information about medical drugs in the Republic of Armenia is provided in order to protect the population against forgery and fraudulent use. All the necessary information for taking the medicine must be listed in the liner. For professionals working in the sphere of circulation of medicines, information about medicines can be given in the form of monographs, reference books, scientific articles, other publications, papers presented at scientific conferences and other similar events, as well as instructions that are intended for physicians who are entitled to prescribe medication.
Dissemination of information about the medicine/drug(s) should also be considered from the point of view of the RA’s law “On Advertising”. It is noted that drug advertising is prohibited without the permission of The Ministry of Health of the Republic of Armenia. The following main categories of banned advertising of drugs: 1) drug advertising, which is issued by prescription only; 2) advertising of medicines containing narcotic substances, as well as, advertising toxic and potent drugs; 3) advertising unregistered medicines in the Republic of Armenia.
In addition to the above one is prohibited to advertise medicines/drug(s) convincing consumers that:
- Use of medication does not require a doctor’s advice;
- Medicine/drug(s) has no side effects;
- It is more effective than other drugs;
- Its use will significantly improve the state of health, while avoiding the use of drug(s) will worsen it;
- It can be used in food, cosmetic or other purposes.
When advertising medical drug(s) in the electronic or print media, one must indicate the registration number in the RA and the number, and date of issue of the permit by The Ministry of Health of the RA. Organizations and individual entrepreneurs engaged in the production and distribution of medical drug(s) are required to indicate in the advertisement the date and their personal license number.
It would be wise to mention another very important point. Distribution of printed, or electronic materials during scientific conferences among professional pharmacists or doctors, is regarded as advertising. According to the official explanation given by The Minister of Health of the Republic of Armenia on 25 January 2013, the production and distribution of information sheets, pens, brochures, notebooks, packages, papers, samples and similar items containing the name of the medical drug(s) to an indefinite number of persons, including to health care workers and public servants, to create or maintain interest in respect of the medical drug(s), is regarded as advertising. Thus, the requirements and restrictions on medical drug advertising as per above apply.
The required license for the manufacture of medicines:
As already mentioned above, the production of medical drug(s) requires a license. The license for the manufacture of a medical drug(s) is given after 30 (thirty) days from the date of submission of the application. The license terms are not limited to a specific time frame. The licenses are valid only at the location specified therein.
To obtain a license one must present the following list of documents:
- An application;
- A list of the required data;
- A positive conclusion of an organization dedicated to conducting examinations of goods, supplies and equipment provided for the implementation of pharmaceutical activity;
- A copy of the applicant’s right to the premises provided for drug manufacturing activities.