We provide a step-by-step guide for pharmaceutical regulatory managers seeking to register products in Armenia. We have outlined the key legislation governing registrations and the regulatory authorities involved in the process.
The guide covers the required application format and contents, registration pathways and timelines, as well as post-approval maintenance requirements and consequences of non-compliance.
By clearly mapping out the registration process and obligations, from compiling the dossier to maintaining the registration certificate, this guide aims to equip regulatory managers with the practical knowledge needed to successfully bring their products to the Armenian market and ensure ongoing compliance.
Legislative Framework Governing Pharmaceutical Registrations in Armenia
The registration of medicinal products in Armenia is governed by several key laws and decrees:
- Law of the Republic of Armenia “On Medicinal Products”: This law regulates the circulation of medicines, substances, herbal substances and preparations, and investigational medicinal products.
- Decree No. 347 of April 25, 2001: “On adopting the Rule of Registration of Medicinal products and Assessment Fees for Registration of Medicinal products in the Republic of Armenia”. This decree, along with subsequent amendments, covers essential aspects of the assessment process, sample quantities, final assessment report templates, registration certificate formats, and a list of variations exempt from new registration.
The Ministry of Health is the main regulatory body responsible for pharmaceutical registration. The Scientific Center of Drug and Medical Technology Expertise conducts the examination of registration materials.
Types of Pharmaceutical Registration Procedures in Armenia
Armenia offers two pathways for registering medicinal products:
- General Procedure: This is the standard pathway for most products, with a registration timeline of up to 150 calendar days.
- Simplified Procedure: An accelerated 30-day procedure is available for products already registered in the EU, US, Japan, or prequalified by the WHO.
“The simplified procedure is used to register medicinal products registered in the EU countries, the USA, Japan or prequalified by the World Health Organization.”
Validity Period of Registration Certificates in Armenia
Registration certificates issued in Armenia are valid for a period of 5 years]. At the expiry of the registration term, the certificate can be renewed through a re-registration process.
Responsible Parties: MAH and Manufacturer
- The registration applicant (holder of the registration certificate) can be the manufacturer or any other legal entity, resident or non-resident of Armenia. The applicant is responsible for the safety, efficacy and quality of the registered products.
- The manufacturer is obligated to comply with GMP requirements and ensure the quality of the medicinal product throughout its lifecycle.
Preparing Your Registration Dossier
A well-prepared registration dossier is the cornerstone of a successful pharmaceutical registration in Armenia. In this section, we will cover the key components and requirements for compiling a comprehensive dossier that meets Armenian standards.
CTD Format Requirements
Armenia follows the Common Technical Document (CTD) format for registration dossiers. The CTD is a globally recognized format that streamlines the preparation and review of regulatory submissions.
It consists of five modules:
- Module 1: Administrative information and prescribing information
- Module 2: CTD summaries
- Module 3: Quality
- Module 4: Non-clinical study reports
- Module 5: Clinical study reports
Dossiers must be submitted both electronically and in paper format to the Scientific Center of Drug and Medical Technology Expertise.
Language Requirements in Armenia
Dossier Languages
The registration dossier can be submitted in Armenian, Russian, or English. If the dossier is submitted in Russian or English, the following documents must also be provided in Armenian:
- Application form
- Instructions for medical use (package leaflet)
- Labeling (mock-ups)
- Prescribing information
- GMP certificate
Translations of Documents
Documents submitted in languages other than Armenian, Russian, or English must be accompanied by certified translations into one of these languages. It is essential to ensure the accuracy and quality of translations to avoid delays in the registration process.
Labeling and Package Leaflets
Labeling and instructions for medical use (package leaflet) must be provided in Armenian. The labeling should comply with the approved artwork, and the instructions should align with the approved summary of product characteristics.
Administrative Documentation
Legalization Requirements
Certain administrative documents in the dossier must be properly legalized. This typically involves notarization and apostille or consular legalization, depending on the country of origin.
Key documents requiring legalization include:
- Power of attorney
- Certificate of pharmaceutical product (CPP)
- GMP certificate
- Certificate of analysis for drug substance and finished product
GMP Certificates
The manufacturing country’s GMP certificate should be included in the registration dossier.
Armenia recognizes GMP certificates issued by:
- Armenian authorities
- EU/EEA authorities
- PIC/S member countries
- US FDA
- Japan PMDA
- Australia TGA
For GMP certificates issued by other countries, a GMP inspection by Armenian authorities may be required.
Samples and Reference Standards
Samples of the finished product and reference standards are required for new registrations, renewals, and changes to quality control methods. The quantities of samples needed are specified in the table below:
| Pharmaceutical Form | Quantity |
| Tablets, capsules, granules, powders | 100 units |
| Suppositories, pessaries | 50 units |
| Parenteral preparations | 50 units |
| Antibiotics for parenteral use | 20 units |
| Sterile powders for injection | 10 units |
| Liquid preparations | 10 units |
| Semi-solid preparations | 5 units |
Import Permits for Samples/Standards
An import certificate is needed to bring the required samples and reference standards into Armenia. The applicant should obtain this permit from the Ministry of Health prior to shipping the materials.
Specialized Documentation
Quality, Safety, and Efficacy Data
The dossier should include comprehensive data demonstrating the quality, safety, and efficacy of the medicinal product.
This includes:
- Drug substance and drug product specifications
- Manufacturing process validation
- Analytical method validation
- Stability studies
- Non-clinical pharmacology and toxicology studies
- Clinical trials
The studies should be conducted in accordance with international guidelines such as ICH, GCP, and GLP.
Stability Studies
Stability data should be provided to support the proposed shelf life and storage conditions of the medicinal product. The stability studies should be conducted on at least three batches of the finished product, covering the proposed commercial packaging.
“The stability studies shall be conducted in the packaging material and transportation packaging proposed for marketing, on not less than three batches of finished product.”
Product Information
The dossier should include the following product information documents:
- Summary of product characteristics (SmPC)
- Patient information leaflet (PIL)
- Labeling (mock-ups)
These documents should be provided in Armenian and align with the data presented in the quality, safety, and efficacy sections of the dossier.
Managing the Registration Process
With a comprehensive registration dossier prepared, regulatory managers can now focus on managing the actual registration process in Armenia.
Step-by-Step Guide to Register a Pharmaceutical in Armenia
- Paying State Fees: The first step in the registration process is to pay the required state fees. The fees for pharmaceutical registration in Armenia are as follows:
- For state registration of medical products: 40,000 Armenian dram
- For medical product trials: 20,000 Armenian dram
- For importing, exporting, distributing, and storing medical products: 100,000 Armenian dram annually
- Submitting Application, Dossier, and Samples: Once the fees are paid, the applicant can submit the registration application along with the complete dossier, product samples, and reference standards to the Scientific Center of Drug and Medical Technology Expertise.
- Preliminary Expert Assessment: The Scientific Center conducts a preliminary assessment of the submitted materials to ensure completeness and compliance with the requirements. If any deficiencies are identified, the applicant will be notified and given an opportunity to provide additional information or clarifications.
- Specialized Examination: After the preliminary assessment, the dossier undergoes a specialized examination focusing on the quality, safety, and efficacy documentation. Experts evaluate the data to ensure compliance with Armenian standards and international guidelines.
- Laboratory Testing: The submitted product samples are subjected to laboratory testing to verify their quality and conformity with the specifications provided in the dossier. This testing is conducted by the Scientific Center or authorized laboratories.
- Pharmacological Board Review: The results of the specialized examination and laboratory testing are presented to the Pharmacological Board of the Ministry of Health. The Board reviews the findings and makes a recommendation on whether to approve or reject the registration application.
- Receiving Registration Certificate: If the Pharmacological Board recommends approval, the Ministry of Health issues a registration certificate valid for 5 years. The approved artwork, instructions, and summary of product characteristics are also provided to the applicant.
Timelines for Standard and Simplified Procedures
The standard registration procedure in Armenia takes up to 150 calendar days from the date of dossier submission. This timeline includes the preliminary assessment, specialized examination, laboratory testing, and Pharmacological Board review.
For products already registered in the EU, US, Japan, or prequalified by the WHO, a simplified procedure is available. This accelerated pathway reduces the registration timeline to just 30 calendar days.
“The standard registration procedure takes up to 150 calendar days. A simplified 30-day procedure applies for products already registered in the EU, US, Japan or WHO prequalified.”
Communicating with the Regulatory Authority in Armenia
Throughout the registration process, regulatory managers may need to communicate with the Scientific Center of Drug and Medical Technology Expertise to provide additional documentation or respond to questions.
Providing Additional Documentation
If the preliminary assessment identifies any deficiencies in the dossier, the applicant will be notified in writing. The applicant should promptly provide the requested additional documentation or clarifications to avoid delays in the registration process.
Responding to Questions
During the specialized examination, experts may raise questions or request further information about the quality, safety, or efficacy data. Regulatory managers should be prepared to provide timely and comprehensive responses to these queries to facilitate the review process.
Registration Outcomes
Approval
If the Pharmacological Board recommends approval and the Ministry of Health concurs, a registration certificate will be issued. The certificate is valid for 5 years and includes the following information:
- Trade name of the medicinal product
- International non-proprietary name (INN) of the active substance(s)
- Pharmaceutical form and strength
- Packaging
- Shelf life
- Storage conditions
- Name and address of the manufacturer
- Name and address of the registration certificate holder
Along with the certificate, the approved artwork, instructions, and summary of product characteristics are provided to the applicant.
Rejection and Re-Application
In case the Pharmacological Board recommends rejection of the registration application, the Ministry of Health will notify the applicant in writing, stating the reasons for the decision.
The applicant may appeal the rejection or address the identified deficiencies and resubmit the application for reconsideration.
Maintaining Your Registration and Introducing Variations
Obtaining a registration certificate is a significant milestone, but it is not the end of the regulatory journey. Regulatory managers must be proactive in maintaining the registration and ensuring ongoing compliance throughout the product’s lifecycle. Following are the key aspects of post-registration obligations, including renewal, variations, and pharmacovigilance.
Validity of Registration Certificates in Armenia
As mentioned earlier, registration certificates issued in Armenia are valid for a period of 5 years from the date of issuance. It is crucial to keep track of the expiry date and initiate the renewal process well in advance to avoid any gaps in the product’s market authorization.
Renewal Process in Armenia
To renew a registration certificate, the applicant must submit a renewal application to the Scientific Center of Drug and Medical Technology Expertise at least 90 days before the expiry of the current certificate. The renewal application should include:
- Application form
- Updated dossier (if applicable)
- Proof of payment of the renewal fee
- Samples of the finished product (if requested)
The renewal process typically follows a simplified procedure, focusing on the product’s safety and efficacy data accumulated during the previous registration period.
The Scientific Center reviews the application and makes a recommendation to the Pharmacological Board, which then advises the Ministry of Health on the renewal decision.
“The applicant shall submit an application for the renewal of a registration certificate to the Center at least 90 days before the expiry of the registration certificate.”
Variations and Changes
Throughout a product’s lifecycle, various changes may be necessary, such as modifications to the manufacturing process, quality control methods, or product information. These changes, known as variations, must be properly documented and submitted to the regulatory authority for approval.
Reportable Changes
Not all changes require prior approval from the Ministry of Health. Some minor variations, such as editorial changes to the product information or minor adjustments to the manufacturing process, can be implemented without prior notification.
However, these changes must still be documented and reported to the Scientific Center in the next periodic safety update report (PSUR).
Changes Requiring New Registrations
Certain significant changes to a registered medicinal product may require a new registration. These include:
- Changes to the active substance(s)
- Changes to the pharmaceutical form
- Changes to the strength or composition of the finished product
- Changes to the route of administration
- Changes to the manufacturing site
For these major variations, regulatory managers must submit a new registration application, following the same procedure as the initial registration.
Pharmacovigilance Obligations in Armenia
Marketing authorization holders have a responsibility to continuously monitor the safety of their registered products and report any adverse reactions to the Armenian regulatory authorities.
Adverse Reaction Monitoring and Reporting
Regulatory managers should establish a robust pharmacovigilance system to collect, evaluate, and report adverse reactions associated with their products. This includes:
- Collecting and reviewing spontaneous reports from healthcare professionals and patients
- Conducting post-marketing safety studies
- Analyzing safety data from worldwide sources
- Preparing and submitting periodic safety update reports (PSURs)
PSURs should be submitted to the Scientific Center of Drug and Medical Technology Expertise according to the following schedule:
- Every 6 months during the first 2 years after registration
- Annually for the next 2 years
- Every 5 years thereafter
“The applicant shall submit periodic safety update reports (PSURs) to the Center every 6 months during the first 2 years following the state registration of the medicinal product, annually for the subsequent 2 years and then once every 5 years.”
In case of any serious or unexpected adverse reactions, regulatory managers must notify the Scientific Center within 15 days of receiving the information.
Consequences of Non-Compliance
Failure to comply with the pharmacovigilance obligations or other post-registration requirements may lead to serious consequences, such as:
- Suspension or revocation of the registration certificate
- Fines and penalties
- Criminal prosecution (in case of severe violations)
To avoid these consequences and ensure the continued safe use of their products, regulatory managers must prioritize compliance and maintain open communication with the Armenian regulatory authorities.
Ready Now to Register Medicines in Armenia?
International pharmaceutical companies may find local expertise invaluable when navigating Armenia’s regulatory procedures. Specialized agencies like Delta Medical, with offices across the Eurasia region,including Armenia, Azerbaijan and Georgia, are well-positioned to guide companies through nuanced registration requirements.
Our on-the-ground presence, relationships with health authorities, and experience submitting regional regulatory paperwork makes accessing these emerging markets more seamless so that companies can focus core efforts on drug development and commercialization. Our targeted guidance to complement your in-house capabilities is key to efficiently securing Armenian registrations.
As a Swiss pharmaceutical company, Delta Medical can also handle marketing, logistics, distribution and sales to help companies achieve successful commercialization in these markets.
Additional Resources
For further information and guidance on pharmaceutical registration in Armenia, regulatory managers can consult the following resources:
- Ministry of Health of the Republic of Armenia: https://www.moh.am/
- Scientific Center of Drug and Medical Technology Expertise: http://www.pharm.am/
- Eurasian Economic Union (EAEU) Common Market of Medicines: https://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx
- European Medicines Agency (EMA) – International Cooperation: https://www.ema.europa.eu/en/partners-networks/international-activities
By leveraging these resources and staying connected with industry peers, regulatory managers can enhance their knowledge and expertise in navigating the Armenian pharmaceutical registration process.