Marketing authorisation

Portugal as Reference Member State

Submission of Marketing Authorisation Applications

Submission of translations (Marketing Authorisation, Renewal and Variation procedures)

Template for revocation/withdrawal of marketing authorisation

MA revocation/ withdrawal request


Contact person for pharmacovigilance issues at national level

Homeopathic medicinal products

Points to Consider on non-clinical safety of homeopathic Medicinal Products of botanical, mineral and chemical origin for human use

Points to consider on safety of Homeopathic medicinal products of biological origin

Application form

Clinical trials

Qualified person declaration concerning investigational medicinal products manufactured in third countries

Statistics of Assessment of Clinical Trials


Training in EudraVigilance

Instructions to Applicants - Submission of Educational Materials

Instructions to Applicants - Submission of Direct Healthcare Professional Communication (DHPC)

Pharmacovigilance Bulletin


Good Manufacturing Practices (GMP)

GMP Guidelines - EudraLex Volume 4

Good Laboratory Practices (GLP)

Note to Applicants for GLP Conformity Assessment

National GLP Compliance Monitoring Program

Portuguese Test Facilities in compliance with GLP


Guidelines for Economic Drug Evaluation Studies

Observatory of Medicinal and Health Products

PPRI - Pharmaceutical Pricing & Reimbursement Information

ESAC - European Surveillance of Antimicrobial Consumption

Regulatory and scientific advice (RSA)

Request for regulatory and scientific advice of medicinal products for human use

Guide for regulatory and scientific advice (RSA)