• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices

 

>>> REGISTER for our free GMP Newsletter LOGFILE

Image

TOP 5 GMP Downloads

1. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

 

2. Quality Agreement
Standard draft to adapt and extend

 

3. Premises
Official requirements | material flow | room classes | and much more...

 

4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers

 

5. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience

 

Your benefits:

> no shipping costs
> no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.

 

>>> Click here to find more Downloads!

News about GMP/cGMP

2010-10-19

EMA: New fees for marketing authorisation applications

The European Medicines Agency (EMA) has changed its rules on fees payable to the Agency. The new fee rules came into operation on October, 7 2010.

 

The revised rules include new, reduced fees for the third and subsequent type-II variations in a grouping or worksharing application, and for additional strengths or potencies of the same pharmaceutical form in an application for an extension of marketing authorisation.
They also include amendments to the fees for grouped variations to plasma and vaccine antigen master files, and to annual fees.

Outcome:

The new fees can be found here:

EMA also published two additional documents related to the new fees:

Sources:

EMA/ Announcement

EMA/ Fees for medicinal products for human use

EMA/ Fees for medicinal products for veterinary use and maximum residue limits

EMA/ Explanatory note on fees payable to the European Medicines Agency

EMA/ Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

Comments
No comment has yet been written about this news.