The Medicines Authority is accepting Scientific Advice and Protocol Assistance requests. This information is intended to make clear how a company should go about requesting scientific advice from the Medicines Authority.
It is the Medicines Authority´s responsibility to give the industry advice by answering questions connected with the development of medical products based on the applicant's documentation. Until further notice, applications considered will be those for generic medicinal products in line with the Medicines Authority's Reference Member State activity.
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 generic medical product, but may also involve a discussion of results of investigations carried out. However, the Medicines Authority does not supply a prior assessment of the documentation with respect to the approval of a generic medical product for sale.
To be able to consider such requests, the following information is requested. Prospective applicants should fill in the specific Scientific Advice Request template and send it to the Medicines Authority at email@example.com.
Written advice will be supplied following receipt of written questions with the company's own position. A face-to-face meeting could be requested by applicants. Fees for this advice will be applicable.
Advice given by the Medicines Authority will be based on the questions and documentation submitted and cannot account for future changes and developments in scientific knowledge or regulatory requirements.
The applicant will submit the appropriate form to the medicines Authority. Relevant specified questions should be included at the time of application (included in the application form). The request should be sent by e-mail to the Medicines Authority at firstname.lastname@example.org
Relevant documentation for the request should be attached. The Medicines Authority will provide advice in writing. Within the Medicines Authority, a contact is appointed who directly gets in touch with the company within two weeks from receipt of the request for advice.
The procedure will start once all the correct documents have been submitted by the applicant and validated by the Authority. Once the procedure has started, a written reply will be is given within 90 days from positive validation.
As per Subsidiary Legislation S.L. 458.46 Medicines Authority (Fees) Regulations of 2007 published under the EURO ADOPTION ACT, 2006 for scientific advice including pre-Submission Meetings with Malta as Reference Member State in MRP/DCP /national procedure (Scientific Advice) the Fee is Euros 2,329.37.
The advice given is not binding, either on the Medicines Authority or on the company.
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