National & international marketing authorisations
Numerous documents need to be submitted for the marketing authorisation of healthcare products – which vary depending on the product category. There are very strict requirements, especially for marketing authorisations for medicinal products: preparing, submitting and maintaining CTD / eCTD documentation places considerable demands on a company's human resources. Diapharm relieves you of this burden.
We will take over and manage all phases of the marketing authorisation procedure for you:
- Centralised procedure (CP) at the EMA
- Decentralised procedure (DCP) in all EU member states
- Mutual recognition procedure (MRP) in all EU member states
- National procedures at all EU drug regulatory agencies (Afssaps, BfArM, DKMA, MHRA, MEB, etc.)
- Regulatory procedures for veterinary medicinal products (e.g. at the BVL)
- Traditional herbal registrations (THR), traditional herbal medicinal products (THMP)
- Preparation of registration files as CTD / eCTD
- Handling of deficiency letters
- Marketing authorisation renewals
In addition to marketing authorisations for medicina products Diapharm manages regulatory tasks for other product categories such as notification, reporting and regulatory procedures, among others:
- Notification procedures for dietary foods
- Compliance assessment procedures for medical devices
- Reporting procedures, e.g. to BfR (cosmetics) or DIMDI (medicinal products)
- Certification procedures, e.g. CE mark for medical devices
- Regulatory procedures, e.g. for health claims for food supplements
- Communication with regulatory authorities
Our experts for regulatory affairs will guide you safely through the numerous and varied national and international procedures. From registration to DCP or MRP approvals procedures - we provide comprehensive support.
