Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Slovenia 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 SLOVENIA – PRICING & REIMBURSEMENT STRATEGY
Reimbursement is handled by two key parties in the Slovenian market: the Health Insurance Institute of Slovenia (ZZZS) is the decision-maker for medicine reimbursement and pricing; with the reimbursement of other health technologies decided by the Health Council at the Ministry of Health.
Although there are some common features, the criteria applied to reimbursement decision-making differ between the two institutions.
The Agency for Medicinal Products and Medical Devices (JAZMP) is the pricing authority for medicinal products. It works relatively quickly and efficiently, and regulation is straightforward and transparent.
Although recognized as being more all-inclusive than is the case in some markets, research shows that there is a need for further reform of the reimbursement policy in Slovenia. Any reform of the reimbursement process must be undertaken within the context of a review of the national healthcare priorities.
The relatively transparent and predictable local regulatory environment requires careful navigation. With experienced locally based consultants, Grove can assist with:
- Understanding the pharmaceutical reimbursement policy in the Slovenian market
- Understanding pricing regulations
- The development of appropriate pricing strategies
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Reimbursement submission
- Monitoring of the status of the reimbursement application
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS – 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 guidelines
- 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 – 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, 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, for example reporting supplies and sales of medicinal products to national authorities
- RA support to meet EU serialization and NMVS (National Medicines Verification Systems) guidelines
- 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 the advertising of medicinal products specifically regulated by the Medicinal Products Act and regulations based on it (the Rules of Advertising Medicinal Products)
- Data protection and GDPR
- Packaging and labelling, to include tracking safety labelling changes
Grove provides market access consultancy services across the following product areas:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Food and dietary supplements