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  • Validation Checklist For Initial Maas - Pharmaceuticals - European ... - Ema Europa

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18 August 2015 EMA/377885/2015 Veterinary Medicines Division Validation checklist for initial MAA pharmaceuticals (applicable to submissions under Art. 12(3) of Directive 2001/82) 1. Background on.

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Obtaining an EU marketing authorisation, step-by-step Steps prior to submitting an application. Submission of the application. Assessment of the application. European Commission decision on the marketing authorisation. Voluntary sharing of market launch intentions: pilot project.

Data on a minimum of 3 production scale batches should be submitted unless otherwise justified.

National Procedure (NP) It is useful for manufacturers who aim to obtain market authorization in specific EU member states. In this procedure, applications are reviewed by the competent authorities of the respective EU member state. Each EU member state has a national procedure of its own.

National authorisation procedures mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries; decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.

EMA is responsible for the scientific evaluation, primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU. EMA was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation, supervision and pharmacovigilance of medicines.

As per the EU directive, an MRP is assigned a review cycle of ninety (90) days followed by a thirty (30)-day national phase to translate the product information in the regional languages.

National authorisation procedures mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries; decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.

The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span. EMA has a committee dedicated to the safety of medicines for human use — the Pharmacovigilance Risk Assessment Committee, or PRAC.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Content Takedown Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232