Last update: February the 5th, 2013

Important Notice: The URL of the applications ECM, LABOFAR, PMPS, MSE & Telematic Submissions have changed

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:
  • Human Medicines
  • Veterinary Medicines
  • Pharmaceutical Inspection and Enforcement
  • Medical Devices, Cosmetics, Hygiene Products and Biocides
  • Online databases
• Request for access
• Related legislation
• See all AEMPS online services
• Information about digital certificates and electronic signature. Known issues

MORE FREQUENTLY USED SERVICES

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)		Yes
Pharmacovigilance: Electronic submission of suspected adverse reactions	FEDRA	-		Yes
Clinical Trials: Authorization, protocol modifications,... Warning: The URL of the application has changed	ECM: Clinical Trials Portal	Submission of applications for clinical trials in CD/DVD		Yes (*)
Search all your authorizations in pdf format and signed electronically	Search all your autorizations in pdf format and signed electronically	-		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)		Yes
Pharmacovigilance of veterinary medicines	VIGIA-VET (foreign access )	-		Yes
Search all your authorizations in pdf format and signed electronically	Search all your autorizations in pdf format and signed electronically	-		No

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,... Warning: The URL of the application has changed	LABOFAR: Pharmaceutical Industry Portal	Submissions of dossiers in CD/DVD for users who do not use LABOFAR		Yes (*)

(*) 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	-		Yes
Reporting the commercialization and putting into service of medical devices Warning: The URL of the application has changed	PMPS	-		Optional

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		No
Medicines with new active ingredients (yellow triangle)	Access to the line listing		No
Authorised medicines for veterinary use in Spain	Veterinary SPC Search		No
Maximum residue limits of veterinary medicines in foodstuffs of animal origin	Access to the searcher	-	No
Wholesaler Directory	Access to the Directory		No
Pharmaceutical Labs Register Warning: The URL of the application has changed	Access to the Register		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.

Related legislation

• Organic Law 15/1999, of 13 December, on the Protection of Personal Data
• Law 59/2003, of 19 December, on Digital Signature
• Law 56/2007, of 28 December, on Measures to Promote the Information Society
• Law 11/2007, of 22 June, on Citizens' Electronic Access to Public Services
• Royal Decree 1720/2007, of 21 December, which approves the Regulation implementing Organic Law 15/1999, of 13 December, on the Protection of Personal Data
• Royal Decree 1671/2009, of 6 November, for the partial implementation of Law 11/2007, of 22 June, on electronic access by citizens to Public Services
• Order SCO/2751/2006, of 31 August, which approves the creation of the Spanish Ministry of Health Telematic Registry for written submissions, requests and communications, and establishes general requirements for telematic processing of certain procedures