AEMPS ONLINE SERVICES

Last Update: 20 July 2017

According to the provisions of Spanish Law 11/2007 about eGovernment, all Regulatory Procedures of the AEMPS can be completed online via the Internet. It is highly recommended to read the documentation of each service before using it.

The access to some of our online services requires a digital certificate to be installed in your browser.

Some of our regulatory procedures requires also the payment of a fee. This payment can also be done online.

MORE FREQUENTLY USED SERVICES

ELECTRONIC FEE PAYMENT

Procedure Application/Portal Dossiers in electronic format More Information Digital Certificate
Electronic Fee Payment and Download Model 317 Electronic Fee Payment and Download Model 317 - More Information No

HUMAN MEDICINES

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) More Information No
Pharmacovigilance: Electronic submission of suspected adverse reactions FEDRA - More Information Yes
Clinical Trials: Authorization, protocol modifications,... ECM: Clinical Trials Portal Submission of applications for clinical trials in CD/DVD More Information Yes (*)
Notifications About Marketing Authorizations of Medicines for Human Use Aplication Software Medicines for Human Use Commercialisation - More Information Yes
Search all your authorizations in pdf format and signed electronically Search all your autorizations in pdf format and signed electronically - More 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 - More 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.

VETERINARY 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) More Information No
Pharmacovigilance of veterinary medicines VIGIA-VET (foreign access) - More Information Yes
Search all your authorizations in pdf format and signed electronically Search all your autorizations in pdf format and signed electronically - More Information No
Intent Marketing About Veterinary Drugs Aplication Software Veterinary Drugs Commercialisation - More Information Yes

See all AEMPS services related to veterinary medicines.

PHARMACEUTICAL INSPECTION AND ENFORCEMENT

Procedure Application/Portal Dossiers in electronic format More Information Digital Certificate
Opening of new Labs, inspection activities, foreign trade,... LABOFAR: Pharmaceutical Industry Portal - More Information Yes (*)

Register of brokers of medicinal products for human use

Register
(You must to use one of these special characters in your keyword: @, #, %, &)
- More 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.

MEDICAL DEVICES, COSMETICS, HYGIENE PRODUCTS AND BIOCIDE

Procedure Application/Portal Dossiers in electronic format More Information Digital Certificate
Authorization and licensing of personal hygiene products, cosmetics,... COSMET: Hygiene and Cosmetics portal - More 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. PMPS - More Information Optional
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 - More Information Si

See all AEMPS services related to medical devices, hygiene products and biocides

ONLINE DATABASES

Database Acceso On-Line More Information Digital Certificate
Authorised medicines for human use in Spain AEMPS Medicines Online Information Center More Information No
Authorised medicines for veterinary use in Spain Veterinary SPC Search More Information No
Maximum residue limits of veterinary medicines in foodstuffs of animal origin Access to the searcher - No
Wholesaler Directory Access to the Directory More Information No
Pharmaceutical Labs Register Access to the Register More Information No

Request for access

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.

If you want to find any information related to this website, please use the search application on the top of the page