As an industry professional, you are responsible for adhering to Good Manufacturing Practice (GMP).

We provide you with all of the essential information and guidance needed for success:

Your requirements, up-to-date and clearly presented; GMP expertise for making informed decisions; Practical implementation support services and safety for daily routine activities

Attach GMP Download PDF Pharmaceutical production for EU markets often occurs outside the EU zone and presents logistics and regulatory challenges for product owners. All stages of manufacturing of medicinal products destined for EU sale should adhere to EU Good Manufacturing Practice (GMP) guidelines in order to guarantee consistent manufacturing process with quality standards met throughout.

This article presents key considerations when importing medicinal products from outside of the European Union (EU).

Wholesale distributors receiving medicinal products from third countries must hold an MIA to import them into the EU, in addition to QP certification and physical importation. An MIA may also be necessary if batch certification occurs at a different site from where physical receipt of importation occurs.

Importers as holders of MIA must comply with GMP standards, which includes creating a pharmaceutical quality system and allocating sufficient personnel and workspace to the relevant activities; planning appropriately for dealing with complaints and recalls; as well as creating protocols to manage their supply chains.

EU GMP guidelines, an agreement should be drawn up between a facility engaged in manufacturing or importation activities and the Marketing Authorisation Holder (MAH), setting out each party’s respective responsibilities – MAH, importer, QP certification site and 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 customs territory in an EU country before being stored under quarantine pending Quality Procerection certification by a Qualified Person (QP). As required by law, QP certification ensures all medicinal products from third countries manufactured according to EU GMP standards are tested when they enter Europe; an MRA or Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAAP) could provide exemption from testing when imported into Europe.

Full batch documentation must be supplied to the MIA holder responsible for QP certification of each batch in order to maintain product quality

Include relevant ordering and delivery documentation as part of batch documentation, as well as details regarding transportation (e.g. temperature monitoring records).

If batches have been split apart and individual quantities imported individually, documentation verifying quantity reconciliation must be provided at the QP certification site.

Information related to your ongoing stability program – such as protocols, results and reports – should also be made available for inspection at your QP certification site as required in Chapter 6 of the EU GMP guidelines.
All documentation must adhere to Chapter 4 of the EU GMP Guidelines, while reference and retention samples obtained must meet specific GMP for Investigational Medicinal Products (IMPs) guidelines, Annex 19 criteria of EU GMP guidelines or both. Furthermore, batches without MRA must undergo quality control testing at a laboratory within Europe such as contract laboratories in order to guarantee both quality and safety upon entering their destination countries.

The QP will certify a batch upon approving of its batch testing results listed below (please refer to Annex 16 of EU GMP guidelines for further details).

https://health.ec.europa.eu/system/files/2016-11/v4_an16_201510_en_0.pdf

Quantitative and qualitative analyses are carried out on active ingredients and other medicine components; all other tests or checks necessary to ensure quality are carried out in accordance with MA requirements.
Importer of Record (IoR)
Prior to import, an Importer of Record is essential, and responsible for ensuring medical devices/goods are imported according to local laws and regulations. Some documents required include:

Product Classification – Specific details on the category and value of imports. Import and Export Licenses – The ability to import products.
Fees/Taxes/Duties – documents required when paying related fees, taxes or duties.
Additionally, IOR must also possess valid Value Added Tax (VAT) numbers as well as EU Economic Operator Registration and Identification numbers that can be presented to local tax authorities (usually the country where imported products will arrive) in order to identify themselves when exchanging information with EU customs authorities.

Responsible Person (RP) services from Saccs can ensure your supply chain complies with current Good Distribution Practice (cGDP). They offer risk assessment and mitigation strategies as well as resource and capacity planning – everything needed for creating a robust supply chain solution tailored specifically for you.

Good Manufacturing Practice (GMP) refers to the minimum standard that every medicines manufacturer must adhere to during production processes. The European Medicines Agency (EMA) coordinates inspections to check compliance with GMP standards, and plays an essential role in unifying GMP activities across Europe.

Any manufacturer supplying medicines intended for sale on the European market must abide by GMP. This requirement must be observed no matter where in the world their operations may be situated.

GMP requirements stipulate the following medicines:

High quality products meet three criteria: they must be of consistent high quality; appropriate to their intended use and adhere to marketing authorisation or clinical trial authorisation regulations.

Legal Framework and Guidance
Three legal instruments outline the principles and guidelines of Good Manufacturing Practice (GMP) within the EU:

Regulation No. 1252/2014 and Directive 2003/94/EC cover active substances and medicines intended for human use

https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice; 
while Directive 91/412/EEC governs those meant for veterinary use 
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:31991L0412&from=EN .
Furthermore, Directives 2001/83/EC and 2001/82/EC also contain relevant provisions. 
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20121116:EN:PDF

The EU GMP guidelines offer interpretation and implementation of these principles and guidelines, with accompanying annexes providing specific advice or modifications for certain product categories or providing more specific guidance on topics of relevance to GMP compliance.

Manufacturing Authorisation Manufacturers and importers located within the European Economic Area (EEA) must possess an authorisation from the national competent authority in each member state where they conduct these activities.

To be eligible for manufacturing or import authorisation, they must comply with EU GMP guidelines. Doing so ensures they fulfil their legal obligations.

Importers have the responsibility of ensuring that third-country manufacturers they source from meet GMP requirements.

Marketing authorisation applicants are responsible for ensuring that any proposed manufacturing sites included in their marketing authorisation applications comply with GMP requirements. For more information, see Section 5.2 Inspections of Pre-Authorisation Guidance.

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance

Manufacturers of active substances intended for human medicines sold on the EU market must register with their national competent authority of where they operate in each Member State where they operate.

Active substance manufacturers must comply with Good Manufacturing Practice (GMP), while manufacturers of finished products must ensure that any active substances they utilize have been produced according to GMP guidelines.

Importers of active substances for sale to EU markets must also register. Each consignment must also come with confirmation from its country of production that meets GMP standards equivalent to those applicable within Europe (unless an exemption exists).

Responsibility for Inspections
Within the EU, national competent authorities are accountable for inspecting manufacturing sites located on their own territories.

Manufacturing sites located outside the EU are usually subject to inspection by the national competent authority of the Member State where an EU importer resides unless there is an established Mutual Recognition Agreement (MRA) between Europe and their host nation; should an MRA exist, both authorities can rely on each other’s inspections as the standards may differ between authorities involved.

When products from outside the EU are imported directly into multiple Member States from their manufacturing site, more than one national competent authority may be responsible for inspecting it. EMA facilitates cooperation among these authorities while overseeing this site.

EU Competent Authorities implement regular inspections based on risk-analysis or when there are indications of noncompliance.