Marketing authorisation
Portugal as Reference Member State
Submission of Marketing Authorisation Applications
Submission of translations (Marketing Authorisation, Renewal and Variation procedures)
Publication of SmPCs and PLs in Infomed from clinical variations and renewals with Portugal as Concerned Member State - Correction
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 safety of Homeopathic medicinal products of biological origin
Clinical trials
Statistics of Assessment of Clinical Trials
Pharmacovigilance
Questions and answers: Adverse Drug Reactions reporting
Instructions to Applicants - Submission of Educational Materials
Instructions to Applicants - Submission of Direct Healthcare Professional Communication (DHPC)
Inspections
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
Reimbursement
Methodological Guidelines for Economic Evaluation Studies of Health Technologies
Observatory of Medicinal and Health Products
PPRI - Pharmaceutical Pricing & Reimbursement Information
ESAC - European Surveillance of Antimicrobial Consumption
Regulatory and scientific advice (RSA)
Simultaneous National Scientific Advice Pilot Project
Request for regulatory and scientific advice of medicinal products for human use
Guide for regulatory and scientific advice (RSA)
