Preparing for Conditional Marketing Authorizations

banderasby Aina Pi

Companies developing medications that meet an urgent need, but lack financial incentive, are rewarded by the European Medicines Agency (EMA) with authorization to go to market earlier than with regular products. Conditional Marketing Authorizations are granted by the EMA for products intended for seriously debilitating diseases, life-threatening diseases and emergency situations. This initiative has been crucial in the growth of investment in orphan medicinal products that treat rare diseases. By giving these companies opportunity to gain traction while still collecting data to truly validate their claims, the likelihood of treatments becoming available in difficult-to-treat areas is increased, for the benefit of European public health.

In order to be granted a Conditional Marketing Authorization, the product must meet several requirements. Firstly, the clinical data must be less than comprehensive. If the data available is sufficient for clear analysis, it should be submitted for full marketing authorization and is not eligible for this initiative. Secondly, the risk-benefit balance suggested by the available data must be positive. Importantly, the applicant is judged to be likely to be able to provide comprehensive data given sufficient time. Furthermore, the relevant medical need must be demonstrated to be unmet thus far. This can include that a major improvement is needed in existing therapy methods. There must also be a degree of urgency to the need, to justify the immediate availability of the product rather than waiting for comprehensive data collection.

A Conditional Marketing Authorization is only valid for one year but can be renewed, the requirements for which are explained below. Once the remaining data has been provided or is no longer required, it can be submitted for full marketing authorization.

Requirements for Conditional Marketing Authorization renewal submission:
Marketing Authorisation Holders (MAH) must apply for an annual renewal at least six months before the expiry date of the Conditional Marketing Authorization. In the case that an MAH does not submit a renewal application, it will expire automatically.

 There is no application form available for annual renewals. Instead, the MAH must submit a cover letter that summarises their claim with the following information annexed:

  1. List of all authorised product presentations for which renewal is sought.
  2. Details of contact persons.
  3. List of EU countries where the product is on the market and indicating for each country which presentations are marketed and the launch date.
  4. Chronological list of all post-authorisation submissions since the granting of the Conditional Marketing Authorization or last renewal and brief description of the change.
  5. Chronological list of conditions and Specific Obligations submitted since the granting of marketing authorisation or last renewal.
  6. A statement, or when available, a certificate of GMP compliance, not more than three years old, for the manufacturer(s) of the medicinal product listed in the application issued by an EEA competent authority or MRA partner authority. A reference to the EudraGMDP database, if available, would suffice.
  7. For manufacturing sites of the medicinal product not located in the EEA (European Economic Area) or in the territory of an MRA partner, a list of the most recent GMP inspections carried out indicating the date, inspection team and outcome.
  8. Summary of Product Characteristics, Labelling and Package Leaflet.
  9. Summary of Pharmacovigilance System (if applicable) and Risk Management Plan.

More detailed information on Conditional Marketing Authorizations is detailed in the Committee for Medicinal Products for Human Use Conditional Authorization Scientific Guideline, found here, and on applications for Conditional Marketing Authorization renewals here.

REFERENCES
Guideline to Implement Commission Regulation (EC) No 507/2006 (2006) Available from:

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004908.pdf Retrieved 22.07.13

Annual Review of Conditional Marketing Authorizations Questions and Answers (2013) Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000133.jsp&mid=WC0b01ac058066e978 Retrieved 22.07.13

EMA Post-Authorisation Procedural Advice (2013) Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf Retrieved 22.07.13

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