All stakeholders involved in the development, manufacture and/or commercialisation of medicinal products for human use, as well as patient groups, healthcare professionals and academia.
Period of consultation
From 27 February 2017 to 22 May 2017.
Objective of the consultation
According to Article 63(e) of Directive 2001/83/EC the Commission, in consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated. The original Guidelines on excipients in the labelling and package leaflet of medicinal products for human use were adopted in 2003. These regulatory guidelines are part of Volume 2C of the Notice to Applicants. An amended version of the Guidelines have been prepared in order to reflect the development since publication of the original version. Opinions of the targeted stakeholders on this amended version are sought.
How to submit your contribution
Stakeholders are invited to comment on this consultation by 22 May 2017 at the latest. Responses should preferably be sent to sante-pharmaceuticals-B5@ec.europa.eu.
They can also be sent by post to Directorate-General for Health and Food Safety, Unit SANTE B/5, BE-1049 Brussels. The subject line of the letter or email should contain the reference "Targeted Public Consultation – Excipients Guidelines".
When submitting your response, please include your name and e-mail address and specify if you are responding as an individual or as a representative of an organisation. If you represent an organisation, please indicate its name and category (company/business; public authority (local, regional, national, international); NGO; patient organisation; other).
If you represent a company, please state whether it falls within the EU definition of a small and medium-sized enterprise (i.e. less than €50 million annual turnover and fewer than 250 employees).
If your organisation is registered in the Transparency Register, please indicate your Register ID number at the beginning of your contribution.
The consultation document
The consultation document can be downloaded here.
Responsible service: Directorate-General for Health and Food Safety - Unit B5 - Medicines: policy, authorisation and monitoring.
Any queries about the public consultation should be sent to this mailbox.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.
Specific privacy statement
Contributions may be published on the Internet. It is important to read the specific privacy statement attached to this consultation for information on how your personal data and contribution will be dealt with.
- Legal framework governing medicinal products for human use in the EU
- Legal framework governing medicinal products for human use in the EU - Major developments
The EU legal framework for human medicines sets standards to ensure a high level of public health protection and the quality, safety and efficacy of authorised medicines. In addition, it promotes the functioning of the internal market, with measures to encourage innovation. It is based on the principle that a medicinal product requires a marketing authorisation by the competent authorities before being placed on the market.
50 years of pharmaceutical legislation
Much of the impetus behind the adoption of the legal framework stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s, when thousands of babies were born with limb deformities as a result of their mothers taking a medicinal product during pregnancy.
This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation.
Since then, a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisation, and post-marketing monitoring, implemented across the entire European Economic Area (EEA).
In the EU, a medicinal product for human use may be authorised either by the European Commission through the centralised procedure or by national competent authorities through a mutual recognition, decentralised or national procedure:
European Medicines Agency (EMA)
National competent authorities
EU countries concerned
The requirements and procedures for marketing authorisation, as well as the rules for monitoring authorised products, are primarily laid down in Directive 2001/83/EC and in Regulation (EC) No 726/2004. They also include harmonised provisions for the manufacture, wholesale or advertising of medicinal products for human use.
Additionally, EU legislation provides for common rules for the conduct of clinical trials (to test the safety and efficacy of medicines under controlled conditions) in the EU. Various rules have also been adopted to address the particularities of certain types of medicinal products and promote research in specific areas:
- Medicinal products for rare diseases (‘Orphan medicines’) (Regulation (EC) No 141/2000)
- Medicinal products for children (Regulation (EC) No 1901/2006)
- Advanced therapy medicinal products (Regulation (EC) No 1394/2007).
All EU legislation in the area of medicinal products for human use is listed in Volume 1 of "The Rules Governing Medicinal Products in the European Union".
To facilitate the interpretation of the legislation and its uniform application across the EU, numerous guidelines of regulatory and scientific nature have been adopted. A detailed explanation of the marketing authorisation procedures and other regulatory guidance is contained in volume 2 (Notice to Applicants).
Quality, safety and efficacy
The authorisation of medicines builds on three key criteria, namely quality, safety and efficacy, to ensure that products administered to patients are of suitable quality and provide a positive benefit-risk balance.
Quality of medicines
When applying for marketing authorisation, companies must provide documentation showing that the product is of suitable quality. This is assessed in accordance with criteria set out in EU legislation (Annex 1 of Directive 2001/83/EC) and guidelines (EudraLex Volume 3).
If the qualitative and quantitative composition of a medicinal product does not meet these standards, the marketing authorisation will be refused, or if the product is already authorised suspended or withdrawn. In such a case all appropriate steps will be taken to ensure that the supply is prohibited and the medicinal product withdrawn from the market.
The manufacture or import of medicinal products itself, including investigational medicinal products, is subject to manufacturing or import authorisation. Due to the impact of manufacturing and distribution practices on the quality of a medicinal product, including its starting materials, a set of rules and good practice guidelinesprovide safeguards against deviation from product specifications, and inappropriate production and distribution practices.
As the manufacturing of medicines and the sourcing of pharmaceutical ingredients is often a global activity the European Commission has intensified global cooperation on different levels with international organisations and other countries.
- Further guidance on quality is provided in EudraLex - Volume 4
Safety and efficacy of medicines
The safety and efficacy of medicines is essential. For new medicines companies are required to demonstrate safety and efficacy through the results of clinical trials. For established compounds, companies can refer either to data from already authorised medicines (generic marketing authorisation) or to published literature (well-established medicinal use).
The data on safety and efficacy will be carefully assessed by the competent authorities before a product receives marketing authorisation. For centrally authorised products this assessment is done by the European Medicines Agency (EMA).
Safety and efficacy continue to be monitored after marketing authorisation, through pharmacoviglance activities, or reviews of the benefit-risk balance.
- Scientific guidance on safety and efficacy of medicinal products is provided in Volume 3
- Safety of medicinal products in the EU
- Video - Safe medicines for the EU
Fees charged by the European Medicines Agency (EMA)
The EMA charges fees for obtaining and maintaining Union marketing authorisations for medicinal products for human use and for veterinary medicinal products and for other services provided by the Agency, according to the Fee Regulation and the Pharmacovigilance Fee Regulation.
- For access to EU pharmaceutical legislation consult EUDRALEX
- EudraBook V1 - May 2015 - Compendium of EU pharmaceutical law
- For a summary of EU pharmaceutical legislation consult SCADPLUS
- Authorisation procedures - The centralised procedure
- Authorisation procedures - National authorisation procedures
- European Medicines Agency
- COM Report to the EP and Council on marketing authorisation procedures of medicinal products for human use
- Conference on "50 years of EU pharma legislation: Achievements and future perspectives"
- Data de publicação
- 27 fevereiro 2017
- Direção-Geral da Saúde e da Segurança dos Alimentos