Entering the European market is not one establishment decision but several. Some roles must sit inside the EEA, some inside a specific Member State, some inside your own organisation, and some can be contracted out. Getting the map wrong is expensive, because the fix is usually a new legal entity rather than a new contract.
The holder must be established in the EEA
Article 8(2) of Directive 2001/83/EC states that a marketing authorisation may only be granted to an applicant established in the Community. Article 2 of Regulation (EC) No 726/2004 puts the same requirement on the holder, and makes the holder responsible for placing the product on the market whether it does so itself or through designated persons. The requirement extends across the EEA through the EEA Agreement.
Note what this does δεν require: establishment in every market you sell into. One EEA entity can hold authorisations valid across all thirty markets.
The pharmacovigilance layer
Article 8(3)(ia) requires the application to identify the qualified person responsible for pharmacovigilance, the Member States in which they reside and carry out their tasks, their contact details, a signed statement on means, and the location of the pharmacovigilance system master file. Article 104(3) requires the holder to have a QPPV permanently and continuously at its disposal, and provides that the QPPV shall reside and operate in the Union.
The master file must be located either at the site in the Union where the holder’s main pharmacovigilance activities are performed, or at the site where the QPPV operates.
Article 104(4) then gives Member States an option: they may require the nomination of a contact person for pharmacovigilance at national level, reporting to the QPPV. Greece has exercised this option, and it is mandatory. Article 136(4) of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/2013 requires a Greek pharmacovigilance contact person with excellent Greek and English, a relevant four-year university degree, at least two years’ practical pharmacovigilance experience, and no reporting line into promotion or sales. EOF states the requirement plainly in its own guidance: there is a national requirement for a local pharmacovigilance contact point for all marketing authorisation holders.
Manufacture, import and batch release
Article 40(3) provides that a manufacturing authorisation is required for imports from third countries. So third-country product needs an EEA-established importer holding a manufacturing and importation authorisation, which under Article 41(c) must have at its disposal at least one qualified person.
Article 51(1)(b) is the operative burden: for product coming from third countries, the QP must certify that each production batch has undergone, in the importing Member State, a full qualitative analysis, a quantitative analysis of at least all active constituents, and all other necessary testing. Batches so controlled in one Member State are exempt from re-control elsewhere. Article 49 sets the QP’s qualifications; Article 51(3) requires certification in a register kept available to the authority for at least five years.
Separately, Article 46(f) requires the manufacturing authorisation holder to verify active substance GMP compliance by audit, and Article 46b(2)(b) requires imported active substances to be accompanied by a written confirmation from the exporting country’s authority unless that country is listed or the plant has been inspected by a Member State.
Distribution
Wholesale distribution requires an authorisation stating the premises on that territory for which it is valid (Article 77). Article 79(b) requires staff including a qualified person designated as responsible — the Responsible Person. The GDP Guidelines (2013/C 343/01) state that a pharmacy degree is desirable, and that the RP should be continuously contactable and may delegate duties but not responsibilities. The Court of Justice confirmed in Case C-47/22 that the RP need not be physically present during an inspection provided they are contactable and on-site staff can answer within their competence.
Greece goes further than the EU minimum here: Article 104 of the Greek transposition requires a Υπεύθυνος Φαρμακοποιός — a responsible pharmacist — with qualifications set by national law. A holder that contracts a licensed Greek wholesaler does not need its own authorisation, but the cooperation contract must be filed with EOF and the holder’s liability persists.
Local representative: optional, and all-or-nothing
Naming a local representative in the package leaflet is not mandatory. Article 59 refers to the holder’s appointed representatives “where applicable”, and EMA’s QRD template states that listing local representatives is not a requirement — but that if they are included in the product information annexes, the full list for all Member States must be given. Article 6(1a) is unambiguous that designating a representative does not relieve the holder of legal responsibility. Under the Greek framework, an appointed local representative is liable independently and in parallel with the holder, and is treated as agent for service.
Medical devices
Article 15 of the MDR and of the IVDR require a person responsible for regulatory compliance available within the manufacturer’s organisation — meaning, per MDCG 2019-07 Rev.1, an employee. Micro and small enterprises may instead have one permanently and continuously at their disposal. Manufacturers outside the Union need a sole authorised representative under Article 11 MDR, which must itself have a PRRC permanently and continuously at its disposal; the two PRRCs cannot be the same person. Article 11(5) makes the authorised representative jointly and severally liable with the manufacturer for defective devices.
How PQRA helps
We map which roles you genuinely need and where, act as or source the Greek pharmacovigilance contact person, provide QPPV and local representation, arrange batch release and importation through qualified partners, structure wholesale arrangements so that EOF filings are correct, and cover authorised representative and PRRC requirements on the device side.
Setting up in Greece or the EU? Let PQRA map the roles before you incorporate.
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