Learner Activity

Slide 39 Activity

Read the following passage.

In the European Union (EU), a license for a medicinal product that is a new chemical entity can be obtained either through a centralized or decentralized procedure. The centralized procedure is probably the best option for smaller companies because only one application, to the European Medicines Evaluation Agency (EMEA), is required. The application is assessed by the Committee on Proprietary Medicinal Products (CPMP), which delivers an opinion within 210 days. An opinion in favor of the product results in a license that is identical in all EU member states. The centralized procedure also allows for the possibility of an expedited review process at the CPMP's discretion.

A company opting for the decentralized procedure would make its application to one or more of the member states. The first member state to issue a license becomes the "reference" member state; the company could then request any or all other EU member states to "mutually recognize" the license within 90 days.

If a product is not a new substance, a sponsor seeking approval for a different indication and/or a different formulation can make an "abridged" application. The nature of this application depends on whether the active substance was originally approved through the centralized, decentralized or (before 1998) a national procedure.

Although the routes to licensure are now consistent throughout the EU, how the product gets to the patient (for example, modes of sale, supply and dispensing) remains entirely at the discretion of each member state.

Source: Microbicides/Spermicidies: Opportunities for Industrial Collaboration. Summary of an International Conference. Durham, NC: Family Health International (FHI), The Consortium for Industrial Collaboration in Contraceptive Research (CICCR)/The Contraceptive Research and Development (CONRAD) Program, The International Working Group on Microbicides (IWGM).

Without rereading the above paragraphs, write down your answers to the following questions.

1. What is the best way to obtain a medicinal product license in the EU for small companies?
2. Who assesses the applications for licenses of medicinal products within the European Medicines Evaluation Agency (EMEA)?
3. Throughout the licensure process in the EU, what is a "reference" member state?
4. What information is essential in reviewing an "abridged" application?

Did you remember enough about the passage to answer the questions? Think about your responses to the following:

1. You read the story yet could not remember much about it. Why? Was it too technical? Was there a lack of interest? Was there no clear relevance to this module?
   
   
2. Why did you find this passage uninteresting? What might you do to make sure your clients listen and retain information you are presenting to them?
   
   
3. What does this activity illustrate regarding the content and communication issues discussed in this module?

This activity illustrates the need to ensure, by use of effective communication techniques, that the technical information that is discussed in a family planning counseling session is understood and retained by clients.