Greece’s low reference prices make it an attractive place to buy medicines and a difficult place to keep them. EOF’s response is a rolling export ban list, refreshed every three months, backed by stock declarations and by notification duties that are stricter than the EU minimum.
Three different things called “parallel”
These get conflated constantly, and the legal treatment of each is entirely different.
- Parallel export is a wholesaler activity: moving product out of Greece under a wholesale distribution authorisation. This is what EOF restricts.
- Parallel distribution is EMA’s notification scheme for centrally authorised products moved between Member States by a distributor independently of the holder, under Article 76(3) and (4) of Directive 2001/83/EC.
- Parallel import concerns nationally authorised products and is authorised by the national authority of the importing Member State.
EMA’s parallel distribution scheme has been mandatory since May 2004, runs through the IRIS platform, and issues roughly 2,500 notices a year. The Agency finalises its check within 60 days of confirming receipt — 35 days of assessment plus up to 25 days of clock-stops — and charges are payable in advance, with the regulatory check starting only once the invoice is paid.
How the Greek export ban works
EOF’s decisions rest on Articles 3(1)(c), 6 and 29 of Law 1316/1983, Article 107 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/2013, and Article 12A of Legislative Decree 96/1973. Note the article: the Greek transposition does not preserve the Directive’s numbering, so the continuous-supply obligation of Directive Article 81 is Greek Article 107, and the Directive’s Article 23a notification duty is Greek Article 39.
The mechanics are consistent across the decision series:
- A temporary prohibition on parallel exports and intra-Community movement of listed products, issued for a three-month period and reissued on expiry with a revised list.
- It binds everyone in the distribution chain — marketing authorisation holders, wholesalers and pharmacies — who must prioritise supply to patients in Greece.
- Stockpiling of listed products is prohibited for the duration.
- A carve-out exists for shipments by holders or their local representatives, or their authorised wholesalers, to Cyprus or another Member State where expressly provided for in a contract.
- Wholesalers must declare their stocks of listed products through EOF’s online stock declaration application, typically at short notice and as at a specified date and time.
Sanctions are substantial. Article 12A of Legislative Decree 96/1973 provides for fines of €30,000 to €1,000,000 where a shortage is caused by a breach by a wholesaler or holder, and €100,000 to €1,000,000 for exporting, or collecting for export, in breach of a ban.
The notification duties, and where Greece is stricter
At EU level, Article 23a of the Directive and Article 13(4) of Regulation (EC) No 726/2004 require the holder to notify a temporary or permanent cessation of placing on the market, other than in exceptional circumstances, no less than two months before the interruption. Article 81 requires holders and distributors, within the limits of their responsibilities, to ensure appropriate and continued supplies so that patient needs are covered.
Greece requires more. Article 39(2) of the Greek transposition requires notification of any interruption of supply, temporary or permanent, at least three months in advance. Law 1316/1983 similarly requires three months’ written notice before any change affecting availability or price. Shortage reports go to EOF through its dedicated reporting application or shortage mailbox, and EOF publishes a list of products with limited availability.
The EU layer above it
The European Shortages Monitoring Platform, established under Regulation (EU) 2022/123, launched its first functionalities in November 2024 and its full set for holders and national authorities in January 2025. Use of the platform became mandatory on 2 February 2025. In normal circumstances, routine shortage reporting through the platform is an obligation on marketing authorisation holders and applies to centrally authorised products; where the steering group announces a preparedness action or the Commission recognises a crisis, reporting extends to nationally authorised products and to national authorities, with scope and frequency set for the event.
Above that sits the Critical Medicines Act. Council and Parliament reached a provisional agreement in May 2026; as of the end of August 2026 it had not been formally adopted, and it awaits endorsement and legal-linguistic revision. The agreed text brings resilience requirements into public procurement of critical medicines, lowers from nine to five the number of Member States needed to request Commission-run collaborative procurement, and extends scope to orphan medicines in certain areas. There is no confirmed application date — plan for the direction, not a deadline.
What this means operationally
- Check the current EOF ban list before any export from Greece, and check again quarterly. Listed products change with each decision.
- Build the stock declaration into wholesale operations — EOF’s windows are short.
- Diarise supply interruptions at three months for Greece, not two.
- Confirm your ESMP reporting obligations for centrally authorised products, and who in your organisation owns them.
How PQRA helps
We monitor the EOF export prohibition decisions and advise on their scope, manage EOF shortage and supply-interruption notifications within Greek deadlines, set up ESMP reporting, prepare wholesale operations for stock declarations and for GDP inspection, and advise holders and distributors on the continuous-supply obligation and its sanctions.
Exporting from Greece, or managing supply into it? Ask PQRA to review your obligations.
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