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Wainwright Associates

Submission of labels and leaflets in the UK

Published date: 
09/04/2012
Summary: 
Submission of labels and leaflets in the UK

The MHRA has announced procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets for medicinal products in the UK.  As a general summary, the MHRA no longer requires mock-ups of the labels or leaflet to be submitted at the start of a procedure; the agency now provides the option of accepting Word versions such as the QRD template at the start of procedure, with the mock-ups to follow before marketing authorisation approval or marketing implementation.  This brings it more into line with the approach followed by other European Membe

On-going Medicine evaluation Information to be published by European Medicines Agency

Published date: 
24/02/2012
Summary: 
On-going Medicine evaluation Information to be published by European Medicines Agency

Following the recommendations on transparency published by the European Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), the EMA has announced that from the 1st March it will publish certain information about centralised marketing authorisation applications (MAAs) for human medicines that have been successfully validated.  Previously such information was unavailable in the public domain.  For innovative medicines, information on the name of the active substance (plus the type of salt, ester or derivative) and therapeutic area will be published.  For

MHRA Inspections of CROs

Published date: 
24/01/2012
Summary: 
MHRA Inspections of CROs

In accordance with the provisions of the new pharmacovigilance legislation, as per Directive 2010/84/EU, EU Competent Authorities may inspect the premises and pharmacovigilance records of both Marketing Authorisation Holders and companies employed by them to perform pharmacovigilance services.

In the UK the MHRA is proposing to establish a scheme to carry out such inspections of service providers. Wainwright Associates’ experienced pharmacovigilance consultants are able to conduct independent audits to enable service providers to prepare for this eventuality.

Payment changes of authority's fees in France

Published date: 
20/01/2012
Summary: 
Payment changes of authority's fees in France

Changes are being made in the way fees are paid for regulatory submissions and procedures in France.  Fees are no longer payable to the French regulatory authority, but will become payable to the State.  Implementation of the arrangements is expected shortly and in the meantime transitional arrangements apply.  National fee rules for Marketing Authorisation Applications (MAAs) and other regulatory procedures can be complex with different authorities having their own national sets of rules to interpret; as with France, these rules may also change from time to time and fee revi

Changes to the EMA’s registration process for SMEs

Published date: 
23/11/2011
Summary: 
Changes to the EMA’s registration process for SMEs

The European Medicines Agency (EMA) has recently made changes to its process for the registration of micro, small or medium-sized enterprises (SMEs) which are expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process.  The financial incentives and support available to registered companies are significant and companies should be encouraged to consider their eligibility from the outset in any European regulatory strategy. 

Pharmacovigilance Compliance Report submission; MHRA’s Risk Based Compliance Programme

Published date: 
20/09/2011
Summary: 
A new version of the MHRA pharmacovigilance Compliance Report (Good Pharmacovigilance Practice Questionnaire) has been released by the MHRA. Submission of a Compliance Report is part of the MHRA’s Risk Based Inspection Programme (with companies who do not submit a report being allocated a higher risk score, and therefore having a higher chance of being subject to an MHRA inspection). Submission of a Compliance Report is recommended every 2 years, with this year’s submission deadline being 4th November 2011. If you would like to discuss your pharmacovigilance requirements, please contact us at enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554

A new version of the MHRA pharmacovigilance Compliance Report (Good Pharmacovigilance Practice Questionnaire) has been released by the MHRA.

Submission of a Compliance Report is part of the MHRA’s Risk Based Inspection Programme (with companies who do not submit a report being allocated a higher risk score, and therefore having a higher chance of being subject to an MHRA inspection). Submission of a Compliance Report is recommended every 2 years, with this year’s submission deadline being 4th November 2011.

First Paediatric Use Marketing Authorisation Granted

Published date: 
14/09/2011
Summary: 
The European Commission has granted the first ever children’s medicine to hold a new Paediatric Use Marketing Authorisation (PUMA). The medicine called Buccolam is now specifically licensed to treat convulsions and epileptic seizures in children. A PUMA will cover the appropriate formulation for the paediatric population. Once granted, the PUMA will benefit from ten years of market protection as a reward for the development. This change is a leap forward in helping to improve the safety, quality and availability of children’s medicines in the EU. The development of medicines for children also require a Paediatric Investigation Plan (PIP) which must discuss all paediatric subsets to be agreed by the Paediatric Committee. If you require assistance with a Paediatric Use Marketing Authorisation or Paediatric Investigation Plan please contact us at enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554.

The European Commission has granted the first ever children’s medicine to hold a new Paediatric Use Marketing Authorisation (PUMA). The medicine called Buccolam is now specifically licensed to treat convulsions and epileptic seizures in children.
A PUMA will cover the appropriate formulation for the paediatric population. Once granted, the PUMA will benefit from ten years of market protection as a reward for the development.

This change is a leap forward in helping to improve the safety, quality and availability of children’s medicines in the EU.

Joint API inspection pilot proves successful

Published date: 
17/08/2011
Summary: 
Joint API inspection pilot proves successful

Over recent years compliance with GMP in the manufacture of active substances (APIs) has been the subject of increasing regulatory interest. In May we reported that the consultation period for the European Medicines Agency’s (EMA’s) proposed template and associated Q&A document for GMP declarations in relation to active substances had ended and we advised applicants to plan accordingly.

Meet Wainwright Associates at the TOPRA Symposium and CPhl worldwide

Published date: 
08/08/2011
Summary: 
Meet Wainwright Associates at the TOPRA Symposium and CPhl worldwide

Wainwright Associates is an independent company offering consultancy services to the pharmaceutical, medical device and healthcare industry in Product Development, Regulatory Affairs, Pharmacovigilance and Licensing.We have a very wide range of experience, gained over many years in the industry at a senior level, which is reflected in the wealth of contract services we can offer. Detailed information regarding the company and its services can be viewed at www.wainwrightassociates.co.uk.

EU Clinical Trials Register is Launched

Published date: 
30/03/2011
Summary: 
The European Medicines Agency (EMA) has announced the launch of its EU Clinical Trials Register.

The European Medicines Agency (EMA) has announced the launch of its EU Clinical Trials Register. This online register allows public access to information on clinical trials for medicines authorised in the EU Member States. The site also contains a search facility which enables the public to search for clinical trials authorised to be conducted outside of the EU if they are part of a Paediatric Investigation Plan.

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