Procedure | Application/Portal | Dossiers in electronic format | More Information | Digital Certificate |
---|---|---|---|---|
Electronic Fee Payment | Electronic Fee Payment | - | Information | No |
Procedure | Application / Portal | Dossiers in electronic format | More Information | Digital Certificate |
---|---|---|---|---|
Marketing authorization and licensing of human medicines, modifications,... | RAEFAR: Registry of Human Medicines and Medicinal Plants | Submission of a dossier in electronic format (eCTD/NEES) | Information | No |
Pharmacovigilance: Electronic submission of suspected adverse reactions | - | - | Information | No |
Clinical Trials: Authorization, protocol modifications,... | ECM: Clinical Trials Portal | Submission of applications for clinical trials in CD/DVD | Information | Yes (*) |
Notifications About Marketing Authorizations of Medicines for Human Use | Aplication Software Medicines for Human Use Commercialisation | - | Information | Yes |
Pharmacovigilance: Registry of Pharmacovigilance Contact Person | Application for the PhV Contact Person registration | - | Information | No |
Search all your authorizations in pdf format and signed electronically | Search all your autorizations in pdf format and signed electronically | - | Information | No |
Management Telematics Technical data sheet and patient information leaflet during the authorization process for a new medicine (provided that it has obtained a favorable report by the CODEM in the national event, or when you launched the translation phase in the case of MRP) and variation of the marketing authorization involving a modification of the texts. | Management Application for PIL & SPC | - | Information | No |
(*) In case of applications without digital signature, it is necessary to send to the AEMPS Registry the cover letter in paper including a handwritten signature and the token provided by the portal.
See all AEMPS services related to human medicines.
Procedure | Application / Portal | Dossiers in electronic format | More Information | Digital Certificate |
---|---|---|---|---|
Marketing authorization and licensing of veterinary medicines, modifications,... | RAEVET: Registry of Veterinary Medicines | Submission of a dossier in electronic format (NEES) | Information | No |
Pharmacovigilance of veterinary medicines | VIGIA-VET (foreign access) | - | Information | Yes |
Search all your authorizations in pdf format and signed electronically | Search all your autorizations in pdf format and signed electronically | - | Information | No |
Intent Marketing About Veterinary Drugs | Aplication Software Veterinary Drugs Commercialisation | - | Information | Yes |
See all AEMPS services related to veterinary medicines.
Procedure | Application / Portal | Dossiers in electronic format | More Information | Digital Certificate |
---|---|---|---|---|
Opening of new Labs, inspection activities, foreign trade,... | LABOFAR: Pharmaceutical Industry Portal | - | Information | Yes (*) |
Register of brokers of medicinal products for human use |
Register
(You must to use one of these special characters in your keyword: @, #, %, &) |
- | Information | No |
(*) In some of the procedures included in LABOFAR, the use of a digital certificate is optional.
See all AEMPS services related to pharmaceutical inspection and enforcement.
Procedure | Application / Portal | Dossiers in electronic format | More Information | Digital Certificate |
---|---|---|---|---|
Authorization and licensing of personal hygiene products, cosmetics,... | COSMET: Hygiene and Cosmetics portal | - | Information | Yes |
Notification of the making available on the market and/ or the putting into service of class IIa medical devices, class IIb medical devices, class III medical devices, active implantable medical devices, self-testing in vitro diagnostic medical devices and in vitro diagnostic medical devices included in Annex II of RD 1662/2000, and modifications.
This application will no longer be operative from 4th July 2018 and it will only remain as a database available for consultation. From this date it will be replaced by the new application, CCPS. |
PMPS | - | Information | Optional |
Notification of the reporting the commercialization and/ or the putting into service of class IIa medical devices, class IIb medical devices, class III medical devices, active implantable medical devices, self-testing in vitro diagnostic medical devices and in vitro diagnostic medical devices included in Annex II of RD 1662/2000, and modifications.
This application replaces PMPS. |
CCPS | - | Information | No |
Registration of persons responsible for placing medical devices on the market: manufacturers/ authorised representatives of class I medical devices, sterile class I medical devices, class I medical devices with measuring function, custom-made medical devices (included custom-made active implantable medical devices), in vitro diagnostic medical devices, performance evaluation in vitro diagnostic medical devices and of persons manufacturing procedure packs or sterilizing medical devices. | RPS: Register of persons responsible for placing medical devices on the market | - | Information | Si |
See all AEMPS services related to medical devices, hygiene products and biocides
Database | On-Line access | More Information | Digital Certificate |
---|---|---|---|
Authorised medicines for human use in Spain | AEMPS Medicines Online Information Center | Information | No |
Authorised medicines for veterinary use in Spain | Veterinary SPC Search | Information | No |
Maximum residue limits of veterinary medicines in foodstuffs of animal origin | Access to the searcher | - | No |
Wholesaler Directory | Access to the Directory | Information | No |
Pharmaceutical Labs Register | Access to the Register | Information | No |
In order to access to some of our online services, a user and a password are required. The way to proceed to request for a user is detailed in the information pages of the applications.