Implementation of registration of medicines in the Republic of Armenia
On the territory of the Republic of Armenia, one is allowed to make, use, sell and import those medicines that are registered in the Republic of Armenia. Registration, refusal of registration or invalidation is carried out by orders of The Ministry of Health of the Republic of Armenia. Each state registration is carried out by individual producers, firms and countries, if a drug is produced in several countries, then by each producing country.
Drugs that are subject to registration in the Republic of Armenia are:
- Newly created (the original) and processed (genetically modified) medicines, including immuno-biological, veterinary and homeopathic medicines;
- Other dosage and/or forms of drugs and indications of already registered drugs;
- New combinations of drugs.
Registration is not required for those medicines that are manufactured in the pharmacy via prescription and in some other cases established by the law of the RA.
The quality of medicines registered in the RA must comply with the country pharmacopeia operating currently. Current valid pharmacopoeias in the RA are: XI State Pharmacopoeia of the former Soviet Union, The European Pharmacopoeia, The International Pharmacopoeia, The Pharmacopoeia of the United States, The British Pharmacopoeia, The German Pharmacopoeia, The German Homeopathic Pharmacopoeia, The French Pharmacopoeia and, in some cases temporary pharmacopoeia articles that have been approved by The Ministry of Health of the RA.
Please note that this registration procedure does not apply to veterinary medicinal products.
Application for registration and examination:
Let us now consider the registration process of medicines. This is a very important procedure within the medical law of the RA and therefore requires a responsible approach from people who have decided to engage in pharmaceutical activities in the Republic of Armenia. Thus, the registration is carried out on the basis of scientific criteria of efficacy and safety studies and expert results. The expertise is carried out by “Expertise Centre of medicines and medical technologies named after academic Emil Gabrielyan,” adjacent to The Ministry of Health of the RA. The Ministry of Health of the RA considers the results of the examination and makes a decision on registration, or refusal of registration of medicines.
The manufacturer or their representative is required to submit an application to The Ministry of Health of the RA. In addition to the application, you need to submit samples of medicines and a list of documents required by The Ministry of Health of the RA. The list of documents can be found on the official website of The Ministry of Health of RA. Documents may be presented in Armenian, Russian or English languages and if possible also submitted in an electronic version.
The fee for the examination must be transferred to the account of the company engaged in the examination of drugs, collected after a preliminary acquaintance with the submitted documents with the applicant notified of the start of the examination. Examinations as a general rule do not last more than 180 (one hundred and eighty) days. Only the examination of drugs registered in one of the countries of The European Union, The United States, and Japan are examined in a simplified manner, without conducting laboratory examination, in a period not exceeding 30 (thirty) days.
Registration of medicines in the Republic of Armenia:
Upon the conclusion of the examination, a report is written up, which within five days post write up is made available to Pharmaceutics Council of the Republic of Armenia. If the examination was carried out in a simplified manner, then the written report goes straight to The Ministry of Health of the RA. The Pharmaceutics Council within 15 (fifteen) days gives its opinion on the drug, registration, or refusal of registration of medicinal products and their inclusion in the list of accepted medicines in the Republic of Armenia. The applicant will receive the final decision within five working days.
The decision on registration shall be made by The Ministry of Health of the RA, within ten days after payment of the state fee by the applicant. It is necessary to make the payment of the state duty, as in the case of non-payment within 30 (thirty) days after giving a positive opinion by The Pharmaceutics Board, the production will cease. This means that for further registration of medicines in the RA one has to go through the same procedure(s) as described above, all over again.
Once the state fee is paid and the drug is registered, The Ministry of Health of the RA within ten working days will issue the applicant a certificate of registration of the said drug, and within 30 (thirty) days after the issue of certificate, the said drug will be included in the State Register of medicines of the RA. The duration of the state registration of medicines in the Republic of Armenia is five years. Extending the duration is done in the same manner as that in which registration takes place (see above).
The information pertaining to changing the packaging and/or labels of drug(s), as well as, information on other changes, must be supplied to The Ministry of Health of the RA within one month. The Ministry of Health of the RA is obliged to provide public information on registered medicines and to publish information about medicines, registration of which has been invalidated.
Refusing the registration of medicines in the Republic of Armenia:
Registration may be refused if:
- There is a negative conclusion, by the Center of expertise of medicines of the RA;
- One has obtained valid and reliable data on adverse effects of the medicine from international specialized sources;
- The medicine contains chlorofluorocarbons (CFCs), except for those drugs, which are approved by the Minister of Health in the list;
- The certificate provided for the registration is forged;
- In cases where the examination was carried out in a simplified manner, one has found that the data does not correspond to the general characteristics of drugs registered in one of the EU countries, the USA or Japan.
When a refusal of registration of medicines in the register is received, the applicant is notified within ten days of the decision. Please remember that in case of failure, the original documents, samples of drugs, as well as, the payment for examination costs are non-refundable. However, the applicant retains the right to appeal the decision of The Health Ministry of the RA in courts.
On declaring the registration of medicines null and void:
After the drug was registered and certified in the Republic of Armenia, it can be invalidated and/or the original decision declared null and void, upon conclusion of the pharmaceutical board or after the examination. This is why it is imperative to always remain vigilant in relation to the production of medicines, which is then supplied to the pharmaceutical market, and monitor the quality of medicines. The Ministry of Health of the Republic of Armenia could invalidate the previous registration of medicines and stop its turnaround in the market(s) if it has received a statement from the producing company, or identified discrepancies established by the RA criteria (detection of new adverse effects) in the exercise of state control over the quality, safety and efficacy of drugs, or if there are confirmed and significant negative data from international specialized sources.
In the event that medication is declared null and void The Ministry of Health of the RA is obliged to publish the information on the recognition of the drug invalid in the media, within ten working days. After the annulment of the drug, it is removed from the state register of medicines of the Republic of Armenia.