Working with its clients to ensure a successful outcome in terms of market access, Grove consultants provide expert advice in three key areas:
- Pricing and reimbursement
- Regulatory affairs (RA) support for local product launch, sales and marketing
- Pharma compliance
- Pharma quality assurance
PHARMA MARKET ACCESS SERVICES IN ARMENIA – PRICING REIMBURSEMENT STRATEGY
The Armenian healthcare sector remains somewhat underdeveloped in comparison to others within the Central and Eastern European region. Although legislation has been agreed to provide for the reimbursement policy, getting from paper to practical implementation has been less than optimal and as a result access to medicines remains a critical issue for much of the population.
Given high levels of out-of-pocket medicine purchases, this is an area which is receiving considerable attention and one where we are likely to see regulatory developments in the future.
As in other areas, the Ministry of Health and the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE) as an agency within the Ministry of Health, play a key role in the market for medicines, medical devices, food supplements and cosmetics.
The still embryonic local regulatory affairs environment requires very careful navigation. In a market where the government continues to struggle to implement any policy for managing prices of pharmaceuticals, if new market entrants are to get their own pricing and reimbursement strategies right, local market knowledge is key.
With experienced local consultants, Grove can assist with:
- Understanding the Armenian reimbursement policy
- The development of appropriate pricing and reimbursement strategies
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Reimbursement applications
- Reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS SERVICES IN ARMENIA – REGULATORY AFFAIRS SUPPORT FOR LOCAL PRODUCT LAUNCH, SALES AND MARKETING
Beyond pricing and reimbursement, locally based consultants provide expert regulatory affairs support for local product launch, sales and marketing. This includes:
- Review of advertising, promotional and educational materials to meet local regulatory requirements
- Validation and submission of relevant materials to appropriate local agencies
- Provision of local management support required/relevant local databases
- Facilitation of direct communication with local healthcare professionals
MARKET ACCESS ARMENIA – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE
Experienced, well-connected local Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant local legislation and regulatory requirements.
Across key product areas of pharmaceuticals/medicines/drugs/medicinal products, medical devices and biologics, food and dietary supplements and cosmetics, areas in which Grove consultants provide regular input to ensure client compliance include:
- Local notifications and authorization support
- Manufacturing, within which QA and good pharmaceutical manufacturing practice requirements must be met
- RA consulting services to meet local distribution prerequisites
- Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
- Advertising, with legislation controlling the promotion and advertising of prescription medicines (regulated by the Ministry of Health) and guidelines in place for the advertising and promotion of non-prescription medicines
- Data protection
- Packaging and labelling
Grove provides market access consultancy services across the following product areas:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Biologics
- Cosmetics
- Food and dietary supplements
