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Comprehensive Guide to Medicinal Product Registration in Armenia: Criteria, Procedures, and Quality Standards

MoH: Armenia Ministry of Health

MoH website: https://www.gov.am/en/structure/1/

Regulatory Authority: Scientific centre of drug and medical technology expertise

Link for Regulatory Authority: https://www.pharm.am/index.php/en/

Overview

The registration of medicinal products in the Republic of Armenia involves adherence to a set of stringent requirements outlined in various legislative acts. The fundamental legal framework comprises the Laws of the Republic of Armenia, specifically the “On Medicinal products” and “On State Taxes” statutes.

Additionally, the Government of the Republic of Armenia has issued Decree No347 of 25 April, 2001, titled “On adopting the Rule of Registration of Medicinal products and Assessment Fees for Registration of Medicinal products in the Republic of Armenia.”

Over time, this regulatory landscape has undergone modifications, as evidenced by amendments introduced through Government Decrees No148-N (3 February, 2005), No1000-N (3 September, 2009), No266-N (10 March, 2011), and No122-N (14 February, 2013).

Further intricacies are addressed in the Decree No1603-N of 25 November, 2010, which focuses on “Rules of Good Manufacturing Practice for Medicinal products,” and the subsequent Decree No1089-N of 26 September, 2013, concerning “Rules of Good Manufacturing Practice Compliance Inspection and Certification of the Medicinal products and APIs in the Republic of Armenia.”

Complementary to these, the Ministry of Health plays a pivotal role, as outlined in the Order No123-N dated 7 February, 2006, which approves “The Procedure of Assessment of Medicinal products for Registration in the Republic of Armenia.”

This order, subject to amendments, covers essential aspects such as the assessment process, sample quantities, final assessment report templates, registration certificate formats, and a list of variations exempt from new registration.

The evolving nature of these regulations is underscored by subsequent amendments introduced through Ministry of Health Orders No665-N (14 June, 2006), No07-N (18 July, 2011), No05-N (7 March, 2012), No13-N (23 April, 2014), and the Order No189-A (6 February, 2014), which pertains to “adopting the maximum amount of GMP compliance inspection fee for the medicinal products and APIs manufactured in the Republic of Armenia” (Annex 13).

Deep Dive into the General Provisions

The regulatory framework for medicinal products in the Republic of Armenia is governed by a set of comprehensive guidelines aimed at ensuring the safety, efficacy, and quality of pharmaceuticals available within the country.

The following key provisions outline the procedures and criteria for the import, production, storage, distribution, sale, and use of medicinal products in Armenia.

1. Registration Authority

– Importation, production, storage, distribution, sale, and use of medicinal products in Armenia are exclusively permitted for those products registered with the Ministry of Health of the Republic of Armenia.

– The Ministry of Health oversees the registration, refusal, and withdrawal of registration for medicinal products, while veterinary vaccines, serums, and diagnostics fall under the purview of the Ministry of Agriculture.

2. Scientific Evaluation and Criteria

– Registration of medicinal products is contingent upon a scientific evaluation that considers criteria such as quality, efficacy, and safety.

– The Scientific Centre of Drug and Medical Technology Expertise after Academician Emil Gabrielyan conducts assessments for medicinal product registrations.

3. Manufacturer and Country-Specific Registration

– Each registration is specific to the manufacturer (firm) and the country of origin, particularly when the same medicinal product is produced in different countries by the same manufacturer.

4. Quality Standards

– Registered medicinal products must comply with the quality standards outlined in Pharmacopoeias currently used in Armenia. These include standards from the XI State Pharmacopoeia of the former USSR, the European Pharmacopoeia, the International Pharmacopoeia, the American Pharmacopoeia, the British Pharmacopoeia, the German Pharmacopoeia, the German Homeopathic Pharmacopoeia, the French Pharmacopoeia, and temporary Pharmacopoeial monographs approved by the Ministry of Health.

5. Categories Subject to Registration

– The Republic of Armenia mandates the registration of new (original) and generic medicinal products, including immunobiological, veterinary, and homeopathic products.

Additionally, new dosage strengths, pharmaceutical forms, and indications of already registered medicinal products, as well as new combinations of medicinal products, require registration.

6. Exemptions from Registration

– Medicinal products produced in pharmacies in accordance with prescriptions and as specified by the Government of the Republic of Armenia may be exempt from registration.

7. Therapeutic and Public Health Interest

– Medicinal products addressing serious or life-threatening diseases or conditions of major therapeutic and public health interest may undergo assessment for registration within the state budget framework.

8. Changes and Variations

– Changes in composition, manufacturing technology, international nonproprietary names, therapeutic indications, or the discovery of new properties necessitate new registration. The Ministry of Health provides a List of variations exempt from new registration.

9. Medicinal Products Register

– Information on registered medicinal products is maintained in the Register of Medicinal Products, regularly published in accordance with Armenian legislation. An electronic version of the register is accessible on the Scientific Centre’s website.

These regulations collectively uphold the standards of medicinal products in Armenia, ensuring that only safe and effective pharmaceuticals are available to the public. The meticulous registration process, periodic assessments, and transparency through the Medicinal Products Register contribute to a robust and regulated pharmaceutical landscape in the Republic of Armenia.

Pharmaceutical / Medicine/ Drug/OTC registration requirements and procedure

· The dossier is submitted both electronically and on paper in CTD format. Part of the administrative documentation must be legalized correctly.

· The dossier can be sent in in English, Russian, or Armenian. If the dossier materials contain information in other languages, their translation into the mentioned languages is required.

· The submission of the instruction is made in English, Russian, or Armenian.

The medicinal product registration procedure in Armenia includes the following steps:

1. Payment of state fees.

2. Submitting a registration dossier, an application for registration, medicine samples, and laboratory control standards.

3. Preliminary expert assessment (the preliminary material assessment).

4. Obtaining a report on the preliminary expert assessment and an expert work cost invoice.

5. payment for professional services and receipt of payment confirmation.

6. Expert assessment of the documentation (quality, safety, efficacy, risk/benefit ratio, production conditions study, documentation of guaranteeing the quality of drug substance and final product, shelf-life reports and stability studies, packaging labeling, usage instructions, etc.) by specialized professionals, during which inquiries concerning the provided documentation or requests for further documentation may be made.

7. Response to the specialist expert evaluation’s remarks.

8. Opinion on laboratory expert assessment and testing of medicine samples’ quality are two aspects of laboratory expert evaluation.

9. Providing expert opinion to the Pharmacological Council.

10. Issuance of an opinion on registration.

11. Receipt of the notification of the opinion on registration.

12. Issuance of the Marketing Authorization, posting of mock-ups, instructions and basic features of the medical product on the web site.

· It is not necessary for laboratory experts to evaluate the samples to register pharmaceutical items in Armenia using a streamlined method. For other pharmaceuticals, reference standards and samples of the completed product are needed for new registrations, renewals, and amendments to quality control procedures. The importer must have an import certificate to import standards and samples.

· The producing nation’s GMP certificate is presented at registration, and a production site inspection is not necessary.

· A Marketing Authorization is granted in the Holder’s name upon registration. Along with the marketing authorization, the package design, usage guidelines, and Summary of Medicinal Product Characteristics (SmPC) are all authorized.

Labelling Requirements

Labelling is approved in Armenian and/or Russian, and/or English.

License validity

05 years.

Registration Period

150 calendar days.

License renewal

After the expiration of the Marketing Authorization and takes 31 calendar days (if there are no changes in the registration dossier of the finished medicinal product from the date of registration of the product on the Armenian market).

Fees

40,000 Armenian dram

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