Ghiduri procedurale, informatii, proceduri standard de operare si modalitatea de depunere a cererilor pentru procedurile descentralizata, de recunoastere mutuala si de utilizare repetata sunt publicate pe website-ul Grupului de coordonare al procedurilor de recunoastre mutuala si descentralizata (CMDh):

GENERAL INFORMATION: https://www.hma.eu/human-medicines/cmdh.html

Application for marketing authorisation (MA): https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma.html

DCP: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma/dcp.html

MRP/RUP: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma/mrp/rup.html

e-Submissions: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/esubmissions.html

Generics: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/generics.html

Applicant’s responses: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/applicants-responses.html

Renewal: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/renewal.html

Consultation with target patients groups: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/consultation-with-target-patient-groups.html

Variation procedure: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html

Article 5 recommendations: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation/art-5-recommendations.html

Article 61.3 procedure: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/art-613-procedure.html

Post-referral phase: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/post-referral-phase.html

CMDh referrals: https://www.hma.eu/human-medicines/cmdh/cmdh-referrals.html

Product information: https://www.hma.eu/human-medicines/cmdh/product-information.html

Advice from CMDh: https://www.hma.eu/human-medicines/cmdh/advice-from-cmdh.html

Templates: https://www.hma.eu/human-medicines/cmdh/templates.html

Questions & Answers: https://www.hma.eu/human-medicines/cmdh/questions-answers.html

Pharmacovigilance: https://www.hma.eu/human-medicines/cmdh/pharmacovigilance.html

Pediatric Regulation: https://www.hma.eu/human-medicines/cmdh/paediatric-regulation.html