It is the MPA´s responsibility to give the industry advice by answering questions connected with the development of medical products based on the applicant’s documentation. Advice may be requested for all medical products, irrespective of subsequent choice of procedure for approval.
This information is intended to make clear how a company should go about requesting scientific advice from the Medical Products Agency.
The Medical Products Agency has for many years received visits from industry delegations of various kinds. The number of visits is large and a considerable amount of work is put into preparations and implementation by the Agency. The government has therefore decided that the MPA is entitled to charge a fee for such work as described below.
It is the Medical Products Agency’s responsibility to give the industry advice by answering questions connected with the development of medical products based on the applicant’s documentation. It is, however, not the Agency’s role to take on the pharmaceutical industry’s responsibility for developing its products.
Advice may be requested for all medical products, irrespective of subsequent choice of procedure for approval.
Advice may be requested on matters concerning the manufacture of a medical product, preclinical or clinical documentation and relate to applications for marketing authorization or for clinical testing. Purely regulatory issues are not affected by this SOP.
The advice aims at facilitating an open dialogue concerning the development work. The questions put by the applicant may be prospective and concern the future development of a medical product, but may also involve a discussion of results of investigations carried out. However, the Medical Products Agency does not supply a prior assessment of the documentation with respect to the approval of a medical product for sale.
The issues described below are not addressed in this document:
- Scientific advice with reference to pharmacolvigilance reporting (not liable for a fee)
- Administrative advice, e.g., choice of procedure, inquiry whether MPA accepts RMS-ship, given that the proposed discussion does not include simultaneous discussion of the documentation for the application, manufacturing authorisation, pharmacovigilance, labelling (not liable for a fee)
- Advice with reference to cases in progress (not liable for a fee)
Request for advice
The applicant will submit the appropriate form to the Medical Products Agency. Relevant specified questions should be included at the time of application (included in the application form). The request should be sent by regular mail or e-mail to the MPA registrar (se contact information to the right).
Relevant documentation for the request should either be attached or sent separately. The documentation should be submitted no later that three weeks ahead of a planned meeting, if not otherwise agreed.
The Medical Products Agency may provide advice in writing, via video/telephone conferencing or at a meeting.
Within the Medical Products Agency, a contact is appointed who directly or by help of an assistant gets in touch with the company within two weeks from receipt of the request for advice. The reference number is given to the company. How to convey advice is decided upon following the contacts´ discussion.
In subsequent correspondence concerning this case, the company must specify the reference number.
Reply in writing
If a written reply is given, the Medical Products Agency must send this within two months from receipt of relevant documentation, at the latest.
Reply at a meeting or in video/telephone conference
As a rule, the meeting is held at the premises of the Medical Products Agency. During the meeting, notes are kept by the Medical Products Agency. Minutes from the applicant may be submitted to the Medical Products Agency. The Agency will acknowledge the receipt of the minutes and may comment on the content. However, the Medical Products Agency will not assure the quality of the contents. The minutes can therefore not be interpreted as a document issued by the Medical Products Agency, or as an official position of the Agency.
The government has decided on the fee for scientific advice (SFS 1993:595), currently SEK 45,000. An invoice will be sent to the applicant after the scientific advice has taken place, with the liability to pay within 30 days.
Consequences of scientific advice
The advice given is not binding, either on the Medical Products Agency or on the company.