[ad_1]
The Health Ministry made an important decision while waiting for the vaccine from China. The “Emergency Use Approval” provision for vaccines was added to the “Regulation for Licensing Medicines for Human Use”.
According to the decision published in the Official Gazette, in cases accepted by the World Health Organization (WHO) or the Ministry of Health in the field of infectious diseases, the emergency use of vaccines will be approved, although they cannot be provide comprehensive data on effectiveness, safety and quality.
IN FORCE
Published in the Official Gazette, “of the Turkish Pharmaceutical Products and Medical Devices Agency, Regulation Amending the Regulation on Licensing of Medicinal Products entitled” decision as follows:
ARTICLE 1 – After article 10, the following article has been incorporated into the Regulation for the Registration of Medicines for Human Use published in the Official Gazette of 1/19/2005 and with number 25705.
Article 10 / A – For vaccines to be used in exceptional cases that seriously threaten public health, which are accepted by the World Health Organization or the Ministry in the field of communicable diseases and for which complete efficacy data cannot yet be provided, safety and quality, the Agency may grant an Emergency Use Approval (AKO) until this data is provided.
An AKO request cannot be made for changes to the therapeutic indications of a licensed product or for the addition of new ones.
The work and transactions relating to AKO applications are carried out in accordance with the provisions of the relevant guideline to be published in accordance with this Regulation.
ARTICLE 2 – The following article has been added to “PART II Records and Special License Conditions” of Annex-1 of the same Regulation.
“8. AKO APPLICATIONS
AKO applications; It refers to the application file prepared in accordance with Part I and, where appropriate, Part III of this Annex, with all the data that the applicant can provide on the efficacy, safety and quality of the product “.
ARTICLE 3 – This Regulation enters into force on the date of its publication.
Article 4 – The President of the Turkish Pharmaceutical Products and Medical Devices Agency will enforce these Regulations.
It may interest you
[ad_2]
