Assessing medicines

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Dossier sections

• Administrative data
• Production process and quality
• Medicine characteristics
• Laboratory tests
• Clinical trials

Company:

Submission of medicine dossier and answering of questions

The medicine dossier consist of 5 parts

The MEB receives a request for authorisation, along with the medicine dossier, from the pharmaceutical company. A standard dossier is made up of 5 parts:

• Production process and quality. Is the medicine of a good and constant quality? The company must describe the entire production process and demonstrate that it meets all the requirements. The same applies to the active substances used and the many obligatory checks.
• Medicine characteristics. Is the medicine easy to recognise, for everyone? The company must provide an exact description of what the medicine looks like (form, colour, packaging), which (active) substances it contains, how the medicine works and how it has to be used. Everything must be clearly stated in the product information and patient information leaflet, in accordance with certain rules.
• Laboratory tests. Is the medicine safe to use? The company must carry out all kinds of obligatory tests, in the laboratory and with animals, and submit all the results to the MEB. The company must also investigate possible interactions between the medicine with other medicines, food or herbs and spices.
• Testing using research subjects. Does the medicine work, for whom and what are the adverse reactions? The company is obliged to test the medicine using various groups of research subjects (healthy volunteers and patients) and submit all the tests and results. Stringent requirements apply to these studies involving research subjects.
• Administrative data. Which medicine is involved? What is it called, where is it made and who is involved in the request?

The MEB checks whether the medicine dossier is complete and starts the procedure.

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MEB Agency

Preparation, assessment and implementation of decisions

In consultation with the medical field

350+ employees with a medical / pharmaceutical background

Medicine Evaluation Board

Independent and specialist judgement

'Is there enough evidence that the medicine works? Do the benefits outweigh the risks?'

'Can the company give assurance on the quality of the medicine and its production process?'

'Should this medicine be ons prescription? Does the patient leaflet contain all required information?'

A maximum of 17 scientist, physicians and/or pharmacists from medical practice

The board meets each week

Benefit

Risks

Quality

Marketing authorisation

Advice to EMA

The MEB assesses the medicine on the basis of the medicine dossier submitted.

• It is important that there is a good balance between the efficacy and the risks of the medicine. The MEB assesses whether the company has submitted sufficient proof that the medicine works and whether the benefits of using the medicine weigh up against the risks and adverse reactions. The results from the tests are very important for the considerations at this stage. However, the MEB also uses its experience with assessing other, similar medicines.
• The quality of the medicine also has to be satisfactory. To establish this the MEB assesses the entire production process. This covers, for example, the medicine's shelf life and whether it is user-friendly.

Very specific knowledge is required for this assessment and, generally speaking, the MEB can draw on the knowledge and experience of its own staff in this respect.

• A 'straightforward' medicine, whereby the decision-making is clear, can be dealt with by employees of the Agency. They do this on the instructions of the Board. They also prepare all the dossiers, consult with the company in the event of questions and process decisions.
• A 'complicated' medicine is dealt with by the Board. The Board is made up of a maximum of 17 independent scientists with a great deal of practical experience.
• In order to maintain good contacts with medical practice the MEB regularly consults umbrella organisations of physicians, pharmacists and professional and patient associations.

After approval by the MEB,  the pharmaceutical company is issued a license and is then allowed to market its medicine in the Netherlands.

The MEB plays an important role in  the authorisation of medicines on the Dutch market. This involves us cooperating with all national medicines authorities within the EU and with the European Medicines Agency (EMA).

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Prescription medicine

Only available at the pharmacy

Non-prescription medicine

Available at pharmacy only, or pharmacy / chemist only, or pharmacy / chemist / general sales.

20,000 medicines on the Dutch market. 65% of all medicines is on prescription.

With regard to the authorisation, the MEB also determines how and where the pharmaceutical company is allowed to market the medicine:

• If a prescription is required, the medicine will only be available from a pharmacy.
• If no prescription is required, the medicine will be available only from a pharmacy, or a pharmacy/drugstore combination, or sales will be unrestricted (supermarkets, petrol stations).

For each medicine the MEB assesses whether people need advice and supervision (and from whom) to ensure the correct use of their medicine. Of the 20,000 medicines on the Dutch market, 65% is available on prescription.

For a medicine to be effective it is extremely important that it is used correctly. That is why the MEB also includes all the practical matters relating to the medicine in the assessment, such as:

• The patient information leaflet: what should users look out for, are all the adverse reactions stated and is the text legible?
• The packaging (legibility, ease of use).
• Any additional information, for example a patient card.

The MEB does not look at the price of the medicine, nor does it assess whether a medicine is going to be reimbursed. That work is done by the pharmaceutical company and the National Health Care Institute (ZiN) and the Ministry of Health, Welfare and Sport (VWS).