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Abridged and bibliographic applications
Abridged applications in the EU are applications made under Directive 2001/83/EC Article 10(1) or 10(c), as amended, whilst bibliographic applications are covered by Article 10(a).
Our area of expertise is the preparation and submission of applications in accordance with the following paragraphs:
- 10(1) – generic application. Previously known as an "essentially similar" application, this type of application is when the applicant cross refers to the dossier of an originator product. The conditions to be met include, but are not limited to,
- the product in question having the same qualitative and quantitative composition in terms of active ingredient,
- the same pharmaceutical form and
- proven in vivo bioequivalence.
The originator product must also be on the market in at least one member state and have been authorised for six or ten years, depending on the country, before the application can be made. However, Directive 2004/27/EC amending Directive 2001/83/EC states that all countries enforce an 8 year data exclusivity rule with respect to submissions and 10 years with respect to marketing for all drug products containing a drug substance submitted for authorisation after the implementation of Directive 2004/27/EC (deadline for transposition 30/10/2005).
- 10(a) – well established use applications. This type of application is also known as a "bibliographic" application as the applicant prepares a dossier on the product based on the literature available in the public domain. The drug product concerned needs to have been on the market for at least 10 years. This type of application is especially important to the newer Member States as it allows them to keep their current generic products on the market where no reference product exists.
- 10(b) – fixed combination applications. This is an application for a drug product which combines more than one known drug substance in one pharmaceutical form such as a tablet or capsule. Results of clinical and pre-clinical tests will be required for this application and consequently it is a "full" application with its own corresponding period of data exclusivity. Note that Paediatric Investigation Plans (PIPs) are required for fixed combination applications.
- 10(c) – informed consent applications. This is where the holder of the originator marketing authorisation (or "licence") allows a second applicant to cross refer to their original dossier. This means that the second applicant does not have to carry out any clinical, toxicological or pharmacological tests of their own.
- 10(3) – "hybrid" applications. Hybrid applications are where the drug product does not necessarily fall within the definition of a "generic" medicinal product but where only bridging studies are provided to supplement the abridged nature of the application.
- 10(4) – "biosimilar" applications. This is where there is an application for a biological medicinal product where the reference medicinal product does not meet the requirements of a "generic" medicinal product because of differences in raw materials or in the manufacturing process.
- Applications for Marketing Authorisations for human medicinal products and traditional herbal medicinal products will be prepared using the new Common Technical Document (CTD) format, as required from 01 July 2003 . This format is common to the EU, US and Japan . It is also acceptable in many other countries such as Switzerland , Canada and New Zealand .
- Ivowen Limited has full eCTD capability
- Applications for Marketing Authorisations for veterinary medicinal products will be prepared using the standard Notice to Applicants format.
- Preparation of Clinical Summaries and Overviews, Non-Clinical Summaries and Overviews and Quality Summaries and Overviews (formerly Clinical, Pre-Clinical and Pharmaceutical Expert Reports)
- Comparisons of the Summary of Product Characteristics (SmPCs) of the originator products in target markets to identify all areas of potential contention between the Health Authorities in the markets of choice.
- Advice on how to meet individual country requirements to ensure a rapid and successful assessment of your dossier.
- Organisation of translations of relevant sections of the application.
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