MORE FREQUENTLY USED SERVICES

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ELECTRONIC FEE PAYMENT

Procedure	Application/Portal	Dossiers in electronic format	More Information	Digital Certificate
Electronic Fee Payment	Electronic Fee Payment	-	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)	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.

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)	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.

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	-	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.

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	-	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

ONLINE DATABASES

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

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.