Local Regulatory Affairs 

We provide extensive support for promotional materials, including regulatory review and submission to national authorities, where required. Our services also cover the creation of Abbreviated Product Information (API) texts, translation into local languages, and setting up processes such as SOPs and IT systems for material review. Additionally, we offer archiving and data management for promotional materials, consultancy on advertising requirements, and training for client teams on compliance with advertising and promotional material regulations.

In addition to local Regulatory Affairs, we offer a range of Local Affiliate Services, including Local Pharmacovigilance (e.g., Local QPPV, ICSR management), Market Access (e.g., pricing and reimbursement strategies), and QA & Compliance (e.g., stock management, product quality complaints). These services provide comprehensive support for biopharma companies, ensuring seamless compliance and effective market access across various countries.

In most EU countries, appointing a local Regulatory Affairs (RA) person is not mandatory and is based on the company's preference. However, having local RA professionals can be highly beneficial as they are familiar with national legislation and have established relationships with local authorities. This localized expertise allows them to address and resolve regulatory issues more efficiently, ensuring smoother compliance and quicker resolution of any challenges that may arise.

Centrally Approved Products (CAP) can be supplied with foreign packaging when national labeling exemptions are granted, typically in cases of supply shortages or urgent public health needs. These exemptions are subject to specific country regulations, so it's crucial to understand local requirements to determine eligibility for using foreign packaging.

Marketing Authorization Holders (MAHs) should consider several key factors before launching a product in the EU, including local regulatory requirements like serialization and contracts with National Medicines Verification Organizations (NMVO). They must also address packaging specifications, such as the blue box and shared packs, and ensure compliance with national numbers, reimbursement applications, price registration, and national compendia setup. Meeting these requirements is essential for successful market entry and regulatory compliance across the EU.

Sunset clause requirements vary by country within the EU, as each member state assesses compliance individually. Marketing Authorization Holders (MAHs) must monitor stock levels in each country and submit exemptions from the sunset clause where necessary. In many countries, these exemptions are required, and in some, like Italy, they may involve a fee. It's essential for MAHs to stay informed about the specific requirements in each member state to ensure compliance.