To import and/or release batches of medicines into the EU/EEA marketplace, a company needs to have a legal presence in the EU/EEA and to hold a Manufacturer’s and Importer’s Authorisation (MIA) granted by the national regulatory authority. A Commercial MIA is difficult and costly to obtain as the regulatory regime in the EU/EEA is onerous.
MIAS Pharma holds an MIA for Batch Release of Commercial Medicinal Products and provides contract QP / QA and RP Services which our clients can utilise as a low cost, low risk stepping stone into the EU market. We provide the following services to facilitate timely commercialisation:
GxP Compliance Reviews
These can be carried out on site or via video conference depending on client preferences. The output from this identifies the preferred distribution network structure for Europe from a GMP / GDP perspective, talking licencing requirements related to product ownership into account. Individual Member States in Europe have different licencing requirements which must be identified as part of planning the supply chain.
If Gaps in the supply chain are found, MIAS Pharma can assist with the qualification and selection of vendors required for Market Access (including pricing and reimbursement per Member State), Packaging & Labeling, Warehousing and Logistics providers. The necessary audits can be conducted and Standard Operating Procedures (SOPs) and QTAs (Quality/ Technical Agreements) can be developed as required.
Support for MA filing
MIAS will provide a QP Declaration for the Marketing Authorisation Application to confirm that the active substance has been manufactured in accordance with the detailed guideline on good manufacturing practice for active substances used as starting materials as required by Article 46(f) of Directive 2001/83/EC. For a QP Declaration to be signed the MIAS Pharma QP needs to have a clear understanding of the API supply chain to demonstrate that each batch of API has been manufactured in accordance with EU GMP and was sourced via the approved supply chain. For the filing, MIAS Pharma can be named as both the Site of Batch Release & the responsibility for the management of Product Complaints and Recalls. A virtual MAH (Marketing Authorisation Holder) service can also be provided on request via MIAS Pharma Channel Partners.
Support for WDA
In order to sell a product in the EU/EEA, the legal entity in the Member State that is conducting the invoicing as owner of the product will need to obtain and maintain a WDA (Wholesale Distribution Authorisation) in that Member State. MIAS Pharma can support the development and maintenance of a Quality System to support a WDA for that legal entity. MIAS Pharma can also provide contract staff (QP, QA and RP) on request.
Use of the MIAS Commercial MIA
In order to add a product to the MIAS Licence all of the clients contract parties are reviewed against EU cGMP (current Good Manufacturing Practice) and cGDP (current Good Distribution Practice) as appropriate, to determine what variations are required to the MIAS Pharma MIA (Manufacturing and Importation Authorisation).
Once the MIAS Pharma QP is satisfied that the client supply chain meets GMP requirements a variation is sent to the HPRA (Irish Regulatory Body) for approval. This approval process can take up to 3 months. On approval QP batch release can occur in line with our clients requirements. Ensuring appropriate Quality standards is not only about batch release. The multiple parties in the supply chain need to meet EU GMP and GDP standards and to comply with the Marketing Authorisation. As an added value solution MIAS can put a dedicated resource in place to oversee the quality of our clients supply chain and to deal with any day-to-day quality-related issues arising.
On request MIAS can also provide end to end solutions to streamline commercialisation activities through our extended partner network. Our extended services include:
- Market Access Strategy
- Legal & Financial Structure Advice
- QP Supply Chain oversight
- Packaging & Labelling
- Reg Affairs (Pre-Approval / Post-Approval)
- Quality System Design
- Audit Program Support
- QA & RP Placements