Post-authorisation procedures support
Obtaining Marketing Authorisation (MA) is undoubtedly a milestone, but it is worth remembering that post-authorisation aspects are an important stage in the product life cycle, and they need to be supervised properly. For example, failure of the MAH to submit the renewal application by the appropriate deadline may lead to a complete loss of the MA. SciencePharma offers a wide range of post-authorisation services helping to keep MA in proper.
Scope of post-authorisation services includes:
- Product lifecycle management covering all types of variations management, line extension application, sunset clause exemption, annual fees, renewals and withdrawals applications
- OTC switches comprehensive support – we have experience in Rx->OTC switches performed in different EU countries, by different EU CA
- MAH transfers application and support, not only in Poland but also in different EU countries
- Promotional materials review
- Medical information service.