Regulatory services
in Armenia

The Scientific Centre of Drug and Medical Technology Expertise (SCDMTE) is responsible for the implementation of Armenian national drug policy to include the registration of medicines and medical devices and pharmacovigilance activities primarily in the form of drug safety monitoring.

Although progress is slow, the SCDMTE is actively involved with the World Health Organization, the Commonwealth of Independent States and the European Directorate for the Quality of Medicines and Healthcare. There is a clear desire to collaborate and harmonize policies where and when possible.

As your local regulatory affairs specialist Grove has access to the key institutions regulating the market, notably, the Ministry of Health and within this, the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE).

Grove provides regulatory services in Armenia in any one of a number of areas and can, if necessary, act as a full-service regulatory consulting branch.

REGULATORY SERVICES IN ARMENIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES

With their comprehensive understanding of local regulatory requirements and procedures, Grove’s regulatory affairs consultants work closely with their clients through the necessary pre-submission and submission activities required. Key within this is:
  • Regulatory consulting - regulatory submissions and registration related services
  • Preparation and submission of relevant documentation for drug, medical device registration and marketing authorization
  • Liaison with local agencies to monitor progress
  • Assistance with packaging/labelling approval (packaging material submissions, labelling compliance/approval)
  • Readability testing for local language Patient Information Leaflets
  • Medical device registration

REGULATORY CONSULTING IN ARMENIA – MAINTENANCE OF REGULATORY APPROVAL/MA

Grove’s in-country regulatory affairs team provides a full support service post-submission, and work with clients in the following areas:
  • Post-marketing applications
  • Marketing authorization transfer services
  • Variations
  • Renewals
  • Notifications
  • Support for the management of national Agency databases
  • Submission of annual specific national declarations
  • Packaging/labelling compliance

REGULATORY AFFAIRS CONSULTING IN ARMENIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS

Completing the full-service regulatory package that Grove’s regulatory affairs specialists provide, Grove will:
  • Monitor local regulatory change and provide appropriate updates
  • Assess national regulatory documentation and provide appropriate updates
  • Ensure compliance with local regulatory requirements given any change in national legislation, regulations and policies
  • Provide relevant safety updates
Key product areas covered:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements