The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in accordance with EU Good Manufacturing Practice (GMP) guidelines if the products are destined for the EU market. It is imperative to ensure that products are consistently manufactured and controlled according to quality standards.
This article outlines key considerations when importing medicinal products from outside the EU.
- Manufacturer/Importer Authorisation (MIA)
To import products into the EU, wholesale distributors receiving medicinal products from third countries must hold a Manufacturer/Importer Authorisation (MIA) for the site where QP certification and physical importation occur. MIA is also required if the location where batch certification is performed is different from the location where the imported product is physically received.
Importers are required to adhere to GMP standards as MIA holders, which include setting up a pharmaceutical quality system, having sufficient personnel and workspace for the relevant activities, planning appropriately for the handling of complaints and recalls, and putting protocols in place to manage their supply chains.
Following Chapter 7 of the EU GMP guidelines, a written agreement should be signed between the premises engaged in manufacturing and importation activities and the Marketing Authorisation Holder (MAH), and should set out the respective responsibilities of the MAH, the importer, the QP certification site and the third country manufacturer.
- Qualified Person (QP) Certification and Quality Control Testing of Imported Medicinal Products
Imported medicinal products must be physically imported and cleared through the customs territory of an EU country and then stored under quarantine upon receipt until released for QP certification. It is a legal requirement that the QP certify the batch to ensure that all medicinal products imported from third countries are manufactured under the EU GMP standards and that products will be tested when imported into the EU unless there is a Mutual Recognition Agreement (MRA) or Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA).
Full batch documentation must be provided to the MIA holder responsible for the QP certification of the batch to ensure continued product quality. (see Annex 21 of the EU GMP guidelines for details)
- Relevant ordering and delivery documentation should be included in batch documentation, such as the details of transportation (e.g., temperature monitoring records).
- If batches have been subdivided and individual quantities imported separately, documentation confirming quantity reconciliation should be provided at the QP certification site.
- Details of the on-going stability programme, such as protocols, results and reports, should also be available for inspection at the QP certification site, as required in Chapter 6 of the EU GMP guidelines.
All documentation must be kept in compliance with the standards of Chapter 4 of the EU GMP Guidelines. Additionally, the certifying QP oversees making sure that reference and retention samples were obtained in compliance with relevant GMP for Investigational Medicinal Products (IMPs) guidelines as well as the criteria in Annex 19 of the EU GMP guidelines. Furthermore, all batches of medicinal products where a MRA is not present must undergo quality control testing in an EU based laboratory (e.g., a contract laboratory) to help ensure the quality and safety of the products entering the destination country.
The QP will certify the batch upon approval of the batch testing results listed below: (see Annex 16 of the EU GMP guidelines for details)
- Quantitative and qualitative analysis of active ingredients and related medicine components. All the other tests or checks necessary to ensure the quality of medicinal products is in accordance with the requirements of the MA.
- Importer of Record (IoR)
During importation, an Importer of Record (IOR) in the destination country is required, as they are responsible for ensuring that the medical devices/goods are imported in accordance with the laws and regulations of the importing country. The following documents are example requirements:
- Product Classification – details of the category and value of the imports.
- Import and Export licenses – permission to import products.
- Fees/Taxes/Duties – documents when paying related fees, taxes or duties.
In addition, the IOR also needs a valid Value Added Tax (VAT) number and a valid EU Economic Operator Registration and Identification (EORI) number, which can be applied to the local tax authorities (usually the EU country where the imported products will arrive) as an identification number for all customs procedures when exchanging information with the EU customs authorities.
Contact us today for further information on importation of medicinal products into the EU. HiTech Health holds Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market. HiTech Health have a team of Qualified Persons (QPs) and Responsible Persons (RPs) available to support your product portfolio.
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