EMA Tag

19 Jun

Posted at 15:07h in Blog

The EMA has published an overview of the recommendations for the use of herbal substances and/or preparations in the paediatric population as set out in the European Union herbal monographs. The document summarises the indications and possible limitations of use in children, based on the assessment of the Committee on Herbal Medicinal Product (HMPC).

The age range and use of herbal medicinal products within this special patient population, are topics often addressed by healthcare professionals. The purpose of this overview is to provide a summary of the information included in the monographs for ease of reference.

The list is divided into two groups of herbal medicinal products:

  • well-established use -WEU: demonstrated sufficient safety and efficacy data (may only be placed on the market after obtaining a marketing authorisation);
  • traditional use -TU- accepted based on sufficient safety data and plausible efficacy (can be marketed after being registered through simplified registration).

The list is derived from the information contained in the EU herbal monographs, as adopted, and can be consulted either by alphabetical order or according to therapeutic areas, for example, constipation, cough and cold, wye discomfort, gastrointestinal disorders, sleep disorders and temporary insomnia, etc.

For each substance the indications in the therapeutic area, possible herbal preparations referred in the monograph, dosage form and method of administration, Target population and Justification for limited use, for example in children, are listed in a tabular list.

SOURCES:

More detailed information is available in the EMA document European Union herbal monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population.

To view all EU herbal monographs go to Herbal: European Union herbal monographs.

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29 Jun

Posted at 16:38h in Blog

Last May, EMA opened a brief, one-month public consultation procedure (13 May 2022 – 13 June 2022), on a draft question and answer document on remote certification of batches by the Qualified Person (QP): “Public Consultation concerning the physical Attendance and the Location of Personal Residency of The Qualified Person“.

The COVID-19 pandemic has affected standard way of working, requiring the need to work remotely to ensure operations under business continuity mode.

To minimise risks of shortages while ensuring that the high standards of quality, safety and efficacy of medicines made available to patients in the EU were maintained, EMA has therefore developed, in cooperation between the European Commission and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human Medicine (“CMDh”), guidance on adapting “regulatory expectations” as a result of the new context created.

This guidance contemplates the possibility that the work of QPs needs to be adapted to allow remote batch certification when on-site presence is not possible. The GMDP inspectors’ working group is currently evaluating the possible flexibility for the physical presence of the QP at the authorised manufacturing site when batch certification or confirmation is carried out routinely and not only on an emergency basis.

The draft Q&A document, published on May 11, discusses the appropriate requirements and conditions for allowing QP work remotely.

The text clarifies that since the ultimate responsibility for the interpretation of EU legislation lies with the European Court of Justice, the content of this document is therefore subject to any other interpretation by the European Court of Justice.

Proceeding from the requirements in Annex 16 regarding validation and certification activities carried out by the QP, the text outlines four clarifications, expressed in question-and-answer form:

1.    Is remote batch certification/ batch confirmation by the QP allowed on a routine basis?

2.    Where remote QP certification / confirmation is allowed on a routine basis, what conditions should apply?

3.    Is the QP required to be a resident in the Member State where the authorised site is located?

4.    What are the technical requirements for the remote access and the signature used for batch certification / confirmation?

Commissione Europea, EMA ed HMAs – Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic

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23 Mar

Posted at 12:40h in Blog

The European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website. These have been discussed and agreed by the GMP/GDP Inspectors Working Group.

The guide, in the form of a question and answer (Q&A), provides further interpretation of the GMP and GDP guidelines published by the European Commission.

On January 28, 2022, Directive 2001/82/EC – EU Code for Veterinary Medicinal Products was repealed, as a result, the legal requirements for veterinary medicinal products have been updated and will be regulated according to Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products. This regulation includes provisions on authorisation, post-authorisation measures, manufacture, import, export, supply and use of veterinary medicinal products, as well as restrictions and sanctions. Accordingly, the questions and answers have been supplemented and updated.

The new chapter deals with requirements for active substances that are used as starting materials for the manufacture of veterinary medicinal products.

The following are some questions that have been answered:

 

  1. Do active substances used as starting materials in veterinary medicinal products have to comply with Good Manufacturing Practices (“GMP”) for active substances for human medicinal products?
  2. Are there new obligations for active substances used as starting materials in veterinary medicinal products under the Veterinary Medicines Regulation?
  3. Is a GMP certificate mandatory for manufacturing sites?
  4. Can inspections conducted by third country competent authorities be considered when deciding whether a Union inspection should be triggered?

 

The complete list of questions and answers is available on the EMA website.

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