The pricing and reimbursement systems in Central and Eastern Europe are notoriously complex and require careful navigation. Only with an understanding of a local reimbursement policy, can new market entrants get their own price and reimbursement strategies and a subsequent reimbursement application right.
PHARMA MARKET ACCESS SOLUTIONS FOR THE CEE COUNTRIES
With experienced Grove local consultants based in Central and Eastern European countries, Grove can assist with a comprehensive range of pharma market access services:
Pricing and reimbursement consulting services
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Timely follow up and communication with experts
- Administrative support at all levels
- Communicating the value of your product to key opinion leaders and healthcare decision makers in the CEE countries
- Pricing & reimbursement feasibility studies and assessments
- Understanding a national reimbursement system and reimbursement policy in any of the CEE countries
- Evaluation of requirements for local pricing & reimbursement submissions
- Preparation of pricing and reimbursement dossiers
- Reimbursement application
- Close communication with authorities regarding reimbursement application progress – value argumentation and evidence generation
- Pricing and reimbursement monitoring activities, such as liaising with local health authorities with regard to product pricing status and changes, reimbursement status (related requests of authorities for documentation, information, translation etc.) and changes in a local reimbursement system
REGULATORY AFFAIRS SUPPORT FOR PRODUCT LAUNCH, SALES AND MARKETING
Beyond pricing and reimbursement, Grove locally based consultants provide regulatory services to support clients’ product launch, sales and marketing. This includes:
- Validation of artworks and local translations for submission in the local markets
- Facilitation of direct communication with local healthcare professionals
- Review of advertising, promotional and educational materials to meet local regulatory requirements in the CEE countries
- Validation and submission to authorities of advertising, promotional and educational materials in full compliance with the industry guidelines and local regulations governing advertising and promotion in a country
MARKET ACCESS – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE
Grove consultants have extensive experience in providing regulatory services to ensure client pharma compliance in terms of relevant legislation and regulatory requirements in the CEE countries. Grove pharma market access services cover the following areas:
- Local notifications and authorization support, for example reporting supplies and sales of
- medicinal products to national authorities and reporting all interactions between pharmaceutical/medical device companies and contacts within the healthcare sector
- Regulatory affairs/RA support in the CEE countries to meet EU serialization and NMVS (National Medicines Verification Systems) guidelines
- Manufacturing, within which pharma quality assurance and good pharmaceutical manufacturing practice requirements for the CEE countries must be met
- Regulatory consulting to meet local distribution requirements
- Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
- Advertising; compliance with the local regulations and requirements
- Data protection and GDPR in the CEE countries
- Packaging and labelling, to include tracking safety labelling changes
Key product areas covered:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Biologics
- Food and dietary supplements
- Cosmetics
