European Union · National competent authorities of the EU member states · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
1
2 requirements
Application fee
-
Every marketing authorisation states whether the medicine needs a prescription. A medicine can be classified as not subject to prescription when it does not meet the prescription criteria. When a switch is approved on the basis of significant new tests or trials, those data are protected for one year against other applicants seeking the same switch. Most non-prescription medicines are authorised at national level. Medicines intended for sale without a prescription, at first authorisation or as a later change of classification.
1. Classification at authorisation or change of classification.
Outcome: Classification as a medicine not subject to medical prescription in the authorisation.
Legal basis: Directive 2001/83/EC, Articles 70 to 75
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in European Union: Centralised well-established use application, Decentralised procedure, Mutual recognition procedure, National procedure under EU rules. See all routes on the European Union page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.