[ SUPRANATIONAL ]
A single market whose requirements are set centrally and applied by national competent authorities — so the rule is common and the inspectorate is not.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
EUROPE
Directive 2001/83/EC, the Community code relating to medicinal products for human use, is the framework instrument; Commission Directive (EU) 2017/1572 of 15 September 2017 supplements it as regards the principles and guidelines of good manufacturing practice and replaced Commission Directive 2003/94/EC. Investigational medicinal products are covered separately by Commission Delegated Regulation (EU) 2017/1569. The detailed expectations practitioners actually work to are the EudraLex Volume 4 guidelines and their annexes. Clinical trials moved to Regulation (EU) No 536/2014, and devices to Regulation (EU) 2017/745 with in vitro diagnostics under Regulation (EU) 2017/746.
Through a manufacturing authorisation granted by the competent authority of a Member State — Article 40 of Directive 2001/83/EC — and through the qualified person who certifies each batch before release. Note where the authority sits: the European Medicines Agency assesses medicines and runs the centralised marketing-authorisation procedure under Regulation (EC) No 726/2004, but it does not grant manufacturing authorisations and does not inspect in its own name; national competent authorities do both, and record the outcome in EudraGMDP. The Directive/Regulation distinction is the other half of the answer — a Regulation applies directly in every Member State, while a Directive must be transposed into national law, which is why manufacturing requirements can differ in detail between Member States and clinical-trial requirements now do not.
WHAT TRANSFERS
Within the Union, a great deal — and that is the point of it. A manufacturing authorisation and a GMP certificate issued by one Member State’s competent authority are recognised across the Union and published in EudraGMDP, and a batch certified by a qualified person in one Member State does not need recertifying in another. Outside it, much less: a centralised marketing authorisation covers the Union and the EEA, not third countries, and importation from a third country requires an EU importer holding its own manufacturing authorisation, with a QP certifying the imported batch — regardless of what testing the exporting site performed. Mutual recognition agreements, including the one with the United States, remove duplicate GMP inspection for covered products; they do not remove the import authorisation or the QP certification step.
Directive 2001/83/EC requires the manufacturing authorisation holder to have a qualified person at its disposal, and batch certification under Annex 16 of EudraLex Volume 4 is that individual’s act, exercised on their own professional judgement. It is not a departmental sign-off, it is not delegable to a committee, and a company procedure cannot direct its outcome.
The revised Annex 1 on the manufacture of sterile medicinal products was published on 25 August 2022 and applied from 25 August 2023, with one exception: point 8.123, on sterilisation of manually loaded or unloaded lyophilisers without barrier separation, was given an additional year to 25 August 2024. Its contamination control strategy is the organising requirement, not an additional document.
Regulation (EU) No 536/2014 applied from 31 January 2022 and repealed Directive 2001/20/EC. New applications have had to go through the Clinical Trials Information System since 31 January 2023, and trials still running under the old Directive had to be transitioned and recorded in CTIS by 31 January 2025. Procedures written against the Directive describe a regime that no longer operates.
Bringing a medicinal product into the Union from a third country requires an EU-established importer holding a manufacturing authorisation, and each imported batch must be certified by a qualified person. Organisations that think of import as a logistics function rather than as a licensed manufacturing activity discover the requirement late and expensively.
The competent authority of a Member State, under Article 40 of Directive 2001/83/EC. The European Medicines Agency assesses medicines and operates the centralised marketing-authorisation procedure under Regulation (EC) No 726/2004, but it does not grant manufacturing authorisations and does not carry out inspections in its own name. Authorisations and GMP certificates issued by national authorities are published in EudraGMDP.
Commission Directive (EU) 2017/1572 of 15 September 2017, which supplements Directive 2001/83/EC as regards the principles and guidelines of good manufacturing practice and replaced Commission Directive 2003/94/EC. Investigational medicinal products are covered by Commission Delegated Regulation (EU) 2017/1569. The working detail is in the EudraLex Volume 4 guidelines and annexes.
It was published on 25 August 2022 and came into operation on 25 August 2023. Point 8.123 — sterilisation of manually loaded or unloaded lyophilisers with no barrier technology separation — was given an extra year and applied from 25 August 2024.
Yes. Importing a medicinal product from a third country is a manufacturing activity requiring an EU-established importer with its own manufacturing authorisation, and each imported batch must be certified by a qualified person before release. A mutual recognition agreement may remove duplicate GMP inspection of the exporting site, but it does not remove the import authorisation or the QP certification.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about European Union: requirements still arrive through the authorities below, and the edition in force is theirs to state.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.