The Turkish Pharmaceutical and Medical Device Institution (the “Institution”) published a draft regulation on the licensing of medicinal products for human use (the “Draft Regulation”) on 8 November 2018. The Draft Regulation, which is expected to come into force within the year 2020, introduces new concepts and significantly changes the licensing procedures for medicinal products currently applied under the Regulation on the Licensing of Medicinal Products for Human Use, published in the Official Gazette dated 19 January 2005 (the “Current Regulation”).
The Draft Regulation has been prepared in line with the European Union legislation, with the aim of clarifying the rules applicable to the licensing process, some of which are not explicitly addressed under the Current Regulation, and facilitating licensing procedures. The Draft Regulation has a lot to offer. Some of the new concepts and changes brought by the Draft Regulation are summarised below.
Electronic filings. Under the Draft Regulation, licence applications and all related correspondence will be exclusively made electronically. As these are currently filed in hard copy forms, this will be the start of a new era in the licensing process for medicinal products.
Scientific advice services. Prior to or during the course of a licensing application process, applicants will be able to seek scientific advice from the Institution at a pre-defined tariff, which is expected to substantially facilitate the licencing process, particularly for the applicants that are not familiar with the Institution’s practices.
Hybrid application. The Draft Regulation introduces a new type of application, in which both the data obtained from a reference product and studies conducted for the new product will be submitted together and reviewed by the Institution. Hybrid applications will be relevant to products that do not qualify as generic products but have some of their characteristics.
Medicinal products not subject to prescription. The Draft Regulation brings an additional approval process for certain medicinal products that are not subject to prescription, such as certain pain killers, anti-inflammatories, or contraceptives. A pre-approval will have to be obtained from the Institution as a pre-requisite to the licencing application process for these products.
Co-marketed products. Applicants seeking to obtain a license for co-marketed products will need to submit a separate undertaking to the Institution, stating that the products subject to co-marketing are identical; that all variation applications will be made simultaneously; and that no other application will be made by the licence owner for an additional production facility with respect to any one of the co-marketed products. These requirements are aimed at ensuring that the licensing of co-marketed products be carried out through a single process.
Licensing periods. The Draft Regulation sets out a timeline for the licensing process. While applicants will be free to file a licence application at any time throughout the year, licencing processes will commence in February, May, August and November. The aim here is to manage and organise the internal resources of the Institution. With this proposed timeline, the review periods are expected to be shorter in practice.
Priority Assessment Board. Another novelty under the Draft Regulation is the establishment of a “Priority Assessment Board” within the Institution. This new body will be in charge of, amongst others, identifying products that bring innovations in terms of treatment and diagnosis, reduce public health expenditures or have strategic importance for the country’s policies. Upon clearance by the Priority Assessment Board, an application for licensing of the relevant product will have priority over others.
Sales permit. Although not explicitly provided for under the Current Regulation, in practice a sales permit is issued for each licensed medicinal product. The Draft Regulation makes it clear that a sales permit must be obtained for a licensed product before its initial offering to the market, and also in case of (i) transfer of place of production from Turkey to abroad or from abroad to Turkey, (ii) change of package size, (iii) transfer of licence, or (iv) expiry of the suspension period for certain licences.
Market release permit. Another crucial item regulated under the Draft Regulation is the market release permit to be required for blood and immunological products. This permit must be obtained before the release of relevant products to the market, which will add a new step to the sale process for these products.
New licence transfer process. A new transfer process contemplated under the Draft Regulation may be interesting for licence holders that intend to abandon a licence. According to the proposed new rules, upon application of a licence holder for cancellation of a licence, an announcement will be made on the Institution’s website. Third parties will be able to file a request to take over such licence. If a third party that qualifies for a licence application requests to acquire the licence, and the current licence holder consents to such transfer, the cancellation process will terminate and the licence will be transferred.
Notification obligations of the licence holder. Licence holders will be obliged to notify the Institution 30 days in advance in the event a licensed product will not be released to the market at a certain point in time. Notification obligations of the licence holder also extend to cases where a product licence is suspended or cancelled, or a product is recalled in any other country due to quality, effectiveness or safety issues.
Licensing in special cases
The Draft Regulation provides for the following new licence types, which do not exist under the Current Regulation:
- Conditional licence. The conditional licence process introduced by the Draft Regulation will expedite the licensing of medicinal products needed for the treatment, diagnosis or prevention of certain dangerous or contagious diseases. A fast-track conditional licence process can be conducted for these products, at the end of which the Institution grants the licence with the condition that the licence holder shall comply with certain obligations to be determined by the Institution.
- Exceptional licence. An exceptional licence application will be available under the Draft Regulation for medicinal products for which no sufficient detail can be provided due to the unavailability of scientific data or the rarity of the therapeutic indications at hand, or if collecting such data would breach medical ethics. Upon obtaining an exceptional licence, the licence holder will need to meet certain safety conditions to be identified by the Institution, and the validity of the licence will be reviewed by the Institution on an annual basis.
- Mandatory licence. Another new licence type contemplated under the Draft Regulation is the “mandatory licence”. Applicants may file for the licensing of products that the President deems appropriate to manufacture under a mandatory licence on grounds of public interest.
As mentioned above, the Draft Regulation is expected to come into force within this year. While there are ambiguities on the implementation of new concepts to be brought by this piece of legislation, these are expected to be clarified once the regulation becomes effective, and guidelines are published by the Institution. The Draft Regulation is currently being reviewed and evaluated amongst sector professionals, and it seems that once it becomes effective, it will greatly enhance the licencing process for medicinal products.