The OGYÉI modified the system of professional
consultation as of June 1 2017. Requests for written
advice must be submitted to the following e-mail address: email@example.com.
The request should contain a completed template request form
as well as the necessary background documentation. The authority
responds to the questions of the applicant within 45 days. It is
also possible to request a personal consultation by sending a
request and the required background documentation to the above
e-mail address. The meeting should take place within 30 days from
the date of the request and the meeting should not last more than
1,5 hours. The applicant must prepare minutes of the meeting,
which must be sent to the OGYÉI with 15 days following
the meeting. The OGYÉI will amend the draft minutes, if
necessary, and send the finalized minutes back to the applicant.
The topics for professional consultation as well as a fee
table have been posted on the homepage of the OGYÉI. As an
example, the fee for professional consultation regarding
pharmaceutical advertising, packaging and documentation is HUF
40,000 + VAT (approximately EUR 130).
New practice from the OGYÉI regarding MAH transfers
The OGYÉI will treat requests for MAH transfers as
notifications as of June 1 2017 and will no longer consider such
requests as variation. The OGYÉI will record the MAH
transfer in its database and in the medicine documentation. The
OGYÉI will inform the MAH of the completion of the above
procedure in writing.
If there is a need for variation of the MA as a result of the MAH transfer (eg, in case of a name change), such variation shall be subject to a separate application and procedure.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.