Last week’s round-up;
05 – 09 October 2020

published 12 Oct 2020

Type II variations and associated fee structure – MHRA Guidance

The MHRA has released a new blog post to help applicants classify changes to their marketing authorisations correctly, either as minor Type IA or IB, or major Type II. Classifying variations correctly the first time around will reduce the risk of a Request for Further Information (RFI) or Validation Correct Request (VCR) and allows applicants to settle the correct associated fee. The MHRA article describes examples of major changes that should be classified as Type II variations, and which have a significant impact on the quality of the product or clinical changes which may have a significant impact on the safety or efficacy of the medicine. The Agency has highlighted that it is the applicant’s responsibility to submit a variation package containing all the relevant information needed for a thorough and complete assessment.

Expert Reports – MHRA Expectations

The MHRA has published a blog post on the Agency’s expectations on expert reports, which are mandatory for all Type II variation submissions. According to the nature of the proposed change, a quality, clinical or non-clinical expert report may be required. A clinical or medical expert should be a suitably qualified medical practitioner, registered with the national registration body in the UK or equivalent in the EU, while a quality expert should be graduated to degree level in an appropriate science subject and should have experience in research, formulation or product development/manufacture, analytical analysis, quality control or pharmaceutical/scientific regulatory affairs. Expert statements should be signed and must be accompanied by the expert’s CV. Further information on the MHRA’s expectations on expert reports may be viewed at the following link:

Ph. Eur. Updates

The EDQM has released the following updates:

• European Supplement 10.4 is now available and will be applicable from the 1st April 2021.

• An Erratum regarding the Erythromycin (0179) monograph in European Supplement 10.4 has been released. The limit of ≤ 1.0 % for impurity M is still present in the revised monograph, however, this should have been deleted. The corrected text published in the Erratum will be included in the print version of the Ph. Eur. Supplement 10.5.

• Pharmeuropa 32.4 has just been released and includes 42 drafts that are open for public consultation until the 31st December 2020.

UK MHRA clarifies how it will handle Orphan Medicinal Products from 1st Jan 2021

MHRA has clarified that it will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application. The MHRA will offer incentives in the form of market exclusivity and full or partial refunds for marketing authorisation fees to encourage the development of medicines in rare diseases. Notably, a waiver from scientific advice fees will also be available for UK based SMEs. The website has been updated with the details of the application process, market exclusivity, sections on Paediatric indications, variation applications and fees. Full details can be found under this link:

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