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

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

2017 - The GMP Regulations Report

Have you considered all last years new regulations?

Make sure you did not miss out on one or the other with our overview of 24 important GMP documents published in 2017.


>>> Read now:
2017-Regulations-Report.pdf

GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

Award for the
GMP Compliance Adviser

GMP knowledge that convinces.

Image

On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".


TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.


2. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.


3. GDP Audit Questionnaire
More than 700 questions with reference to regulations.


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


>>> More Downloads

News about GMP/cGMP

2018-08-24

UK Government Prepares for "No-deal Scenario" with EU

Even though it is unlikely to happen, the UK government has got its plan B if, in any case, a no deal scenario for leaving the EU might materialise. Guidance thereto was published by the Department for Exiting the European Union on August 23, 2018.

 

If there is no deal after 29 March 2019

The documents “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal” outline changes for human medicines regulations that would no longer be subject to EU rules should the UK leave the EU without a Brexit deal in March 2019. This includes

  • regulations in general,
  • batch testing medicines and,
  • the submittance of regulatory information on medical products.

The MHRA is planning to publish further guidance on the regulatory framework including biological medicines, IT systems requirements, manufacturing, and import licensing in early autumn this year. This includes a public consultation on the required changes of the UK Human Medicines Regulations of 2012. Medicines on the UK market that have a UK Marketing Authorisation (MA) will not be affected by Brexit. New medicines will also need a UK MA once the UK is no longer participating in the EU. Therefore, centrally authorised products which come to the market via a licencing route overseen by the EMA so far, will be automatically converted to UK MA after Brexit. An initial MA application to market a product in the UK will be required for an MHRA assessment.

For batch testing the MHRA will continue to

  • accept batch testing of human medicines carried out in countries on a list from the Medicines and Healthcare products Regulatory Agency (MHRA)
  • require a UK, EU or EEA-based qualified person (QP) to certify batch testing.

If no deal is reached for submitting regulatory information on medical products,

  • the UK would no longer be part of the EU medicines and medical devices regulatory networks, and
  • regulatory information relating to human medicines, medical devices and e-cigarettes would have to be submitted directly to the MHRA.
Source:
Comments
No comment has yet been written about this news.
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (monthly subscription)
GMP Fundamentals – A Step-by-Step Guide (download)
Data Integrity in the EU