Import vs. Manufacturing: Any Differences in the EU?

By now most people understand that "Import" refers to goods coming from third countries into the EU and not to movement of goods between Member States. Importers of medicinal products are required to hold a Manufacturing Authorisation (MIA). Movement within the EU on the other hand, is subject only to the holding of a Wholesale Distribution Authorisation. All of the requirements for and obligations of, Manufacturing Authorisation holders (MIAHs) therefore apply to importers. Requirements include personnel, premises and equipment for import, control, storage and distribution as well as having the services of a Qualified Person (QP). Obligations include:

• Compliance with the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products.
• Using only active substances, which have been manufactured in accordance with GMP for active substances and distributed in accordance with good distribution practice (GDP) for active substances, and verifying this through the conduct of audits.
• Ensuring that the excipients are suitable for use in medicinal products by ascertaining what the appropriate GMP is and verifying that this is applied (does not apply in the case of veterinary products at present).
• Informing the competent authority and the marketing authorisation holder (MAH) immediately if information comes to light that medicinal products within the scope of the MIA are, or are suspected of being, falsified (does not apply in the case of veterinary products at present).
• Verifying the authenticity and quality of the active substances and excipients used.

In so far as the duties of the Qualified Person (QP) are concerned, the wording of the respective legislation is confusing. For imported medicinal products readers of the relevant articles (articles 51(55) of Directives 2001/82) could be misled into believing that the QP only needs to certify that each batch undergoes a full qualitative and quantitative analysis within the EU, unless a Mutual Recognition Agreement (MRA) applies, when analysis performed by the third country manufacturer can be accepted. Contrast this with Annex 16 of the GMP Guide, which comprehensively describes a QP certification process that applies equally to products manufactured in the EU and to imported products. In summary, in addition to testing, imported products must be certified as having been produced in accordance with GMP (elsewhere the legislation clarifies that this means in accordance with GMP standards equivalent to those that apply in the EU) and conforms to the requirements of the Marketing Authorisation (MA).

This text is an excerpt of the article "Why we need Annex 21: GMP for Importers", by David Cockburn, member of the EQPA Board of Directors and former Chair of the EMA GMP/GDP IWG, published in the EQPA Newsletter, Issue 8, June 2018. David Cockburn will also speak at the joint ECA/EQPA Conference After the MRA: Understand European GMPs and the Role of the Qualified Person (QP), August 28-29, 2018, Chicago, Il, USA .