Spain, through the European Union route · European Medicines Agency · Combination products
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
When a device and a medicine form a single integral product meant only for use in that combination and not reusable, such as a prefilled syringe, the whole product is authorised under medicines law. The device part must meet the general safety and performance requirements of the medical devices regulation. If the device alone would need a notified body, the dossier includes a notified body opinion on the device part. Single integral products that combine a medicine and a device, intended only for use together and not reusable.
The official review target is 210 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Notified body opinion on the device part (if needed); 2. Medicine marketing authorisation application; 3. Medicine review (210 days).
Outcome: A marketing authorisation for the medicine, through the centralised or a national route, covering the device part.
Legal basis: Regulation (EU) 2017/745, Article 1(9) and Article 117; Directive 2001/83/EC, Annex I, Section 3.2(12)
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).
About 210 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Centralised time limit for the committee opinion when the medicine uses the centralised route. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: Centralised marketing authorisation, new active substance, Centralised marketing authorisation, known active substance or new fixed combination, Centralised hybrid application, Centralised biosimilar application, Centralised well-established use application, Device with an ancillary medicinal substance: medicines authority consultation, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), Orphan designation, Paediatric investigation plan, Decentralised procedure, Mutual recognition procedure, National procedure under EU rules. See all routes on the Spain 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.