20.12.2019 Tarihli ve E.220773 Sayılı İlaçların Piyasada Bulunabilirliğinin Sağlanması, ENG
MINISTRY OF HEALTH
OF THE REPUBLIC OF TURKEY
Medicines and Medical Devices Agency of Turkey
Number : 16358815-000-E.220773
Subject : Ensuring Market Availability of Medicines
NORMAL
20.12.2019
ASSOCIATION OF RESEARCH-BASED PHARMACEUTICAL COMPANIES
Söğütözü, 2176. Sk. Platin Tower Business Center No:7
D. 52-55, 06700 Çankaya / ANKARA
Patient complaints are received by the Department of Economic Evaluations and Medicine Supply Management of
our Agency regarding non-availability of some medicines on the market despite being registered in Turkey. In order to
ensure that patients are not negatively impacted within the framework of annexed circular and considering the interests
of our country as well, it is necessary to notify us until the 10
th
day of each month the names of the products (of the
previous month);
- for which registration cancellation has been requested,
- which cannot be placed on the market due to the reasons associated with the manufacturing site of the
active substance or the manufacturing site of the product,
- which have recently received registration but cannot yet be placed on the market as they expect their
sales permit,
- which expect to receive their price and thus cannot be placed on the market; furthermore, it is necessary
to notify us at least 1 month ahead on when these products will be placed on the market to ensure that
no negative impact is incurred.
It was communicated with all relevant stakeholders via the letter dated 22.06.2017 that in case of failure
to supply products which are on the market, it is necessary to notify us at least 3 (three months) before product
stock-out. However, it was identified that some companies do not duly make such notifications. I hereby submit
for your information and kindly request for the relevant action to ensure that due care is displayed regarding
this topic and that the referred matters are communicated to the member companies of your association.
Dr. Hakkı GÜRSÖZ
President of the Agency
Annex:
1- Circular on Market Availability of Medicines (2 pages)
DISTRIBUTION:
1- Pharmaceutical Manufacturers Association of Turkey (IEIS)
2- Association of Research-Based Pharmaceutical Companies of Turkey (AIFD)
3- Turkish Pharmaceutical Industry Association (TISD)
4- Self-Care Products Association (SURDER)
5- Association of Innovator Pharmaceutical Companies (GIFD)
MINISTRY OF HEALTH
OF THE REPUBLIC OF TURKEY
Medicines and Medical Devices Agency of Turkey
Internal Correspondence No. : İY 20459 – 1499501
Internal Correspondence Date : 20.11.2014
Number : 75642246-506.99
Subject : Market Availability of Medicines
CIRCULAR
2014/11
As known, article 56 of the Constitution guarantees the “right to health” and the State is
assigned with the duty to plan healthcare institutions and provide healthcare services for the purpose
of fulfilling this right. This task assigned to the State for “healthcare services” with the referred
provision is executed via our Ministry and its affiliated institutions as per Decree Law dated
11/10/2011, with No. 663, on the Organization and Duties of the Ministry of Health and its Affiliated
Institutions.
Within this scope, the following statement is stipulated in items (a) and (d), respectively, of
clause two, article 2 of the Decree Law No. 663, where the duties of the Ministry are indicated: (a)
“Protection and development of public health, mitigation and prevention of disease risks”; (d)
“Ensuring availability of the medicines, special products used in healthcare services, substances
subject to national and international control, active substances and excipients used in pharmaceutical
production, cosmetics and medical devices in a safe and high quality manner, their provision to the
public and designation of their prices”.
Also the following tasks, stipulated in items (a) and (d), respectively, of clause two of article
27 of the same Decree Law are indicated to be among the duties and powers of our Agency: (a) “To
designate the rules and standards of the regarding the registration, production, storage, sales,
import, export, market supply, distribution, putting into service, collection and utilization of the
products included into its sphere of duty, to authorize, grant registration to, inspect and apply
sanctions, where necessary, and conduct or commission the conduct of laboratory analyses of public
and private and legal entities and real persons that will carry out these activities”; (d) “To adopt
relevant measures for ensuring continuous availability on the market of medicines, medical devices
and products of vital importance”.
Thus, the production, import, market supply, quality, content, promotion and similar matters
related with medicinal products for human use in our Country are essentially regulated by Law No.
1262 on Pharmaceutical and Medicinal Preparations; the individual provisions in this Law clearly
foresee that during the production, export of medicinal preparations, their provision to and utilization
by the patients, medicines are duly produced, are not open to degradation, avail of the therapeutic
qualifications reported in line with their formulation as detected by analyses and tests and do not give
rise to any health issues when used and authorize and thus keep liable our Agency for ensuring that
preparations are freely sold with or without the need for a physician’s prescription and designating
and specifying how the medicine will be used as well as other matters.
As per abovementioned provisions, our Agency is assigned with and authorized to execute
the registration transactions of manufactured and import medicines and adopt any kind of measure
for ensuring market availability of medicinal products for human use which have a vital importance
and are indispensable.
Within this framework, the production, import, export and market availability of medicinal
products for human use, prepared for the purpose of treating and/or preventing a disease, making a
diagnosis or correcting, restoring or modifying a physiological function, is important in terms of
public health.
Hence, prior to the market introduction of medicinal products for human use in our Country,
the demand for such medicines is identified upon making a market research and medicines are
produced and placed on the market accordingly. Prior to the market supply of these products, the
manufacturing site comprising all production phases of the products are inspected by our Agency as
per the provisions of the Regulation on the Registration of Medicinal Products for Human Use, a
GMP Certificate is issued to the manufacturing sites identified and certified to carry out production
within the framework of Good Manufacturing Practices and import is allowed only for products
fulfilling these conditions.
Essentially, as medicinal products for human use are directly related with human health unlike
many products and are thus associated with public health, our Agency is actually responsible for and
authorized to regulate and inspect the procedures and principles of this field and, hence, considering
the fact that the procedures required before the market placement of the referred products in
accordance with the relevant legislation are very costly and time-consuming and the importance of
their market placement and availability in terms of public health, it is necessary and mandatory for
our Agency to adopt relevant measures in this field.
Thus, the State intervenes directly or indirectly in medicine prices and thus prices in the
pharmaceutical sector are not composed under free market conditions. Therefore, considering that the
pharmaceutical sector is a sector with significant price difference between countries, it is also obvious
that price variability between countries will make importation between these countries profitable
which is an important topic for the pharmaceutical sector.
Under these conditions, the exportation of the medicinal products for human use, permitted to
be manufactured and imported for our Country, to other countries after their market placement
prevents the market availability of these products thus giving rise to major problems in the
procurement of medicines at a sufficient amount to our patients and causing a significant threat for
public health.
As such, in order to ensure market availability of medicinal products for human use permitted
to be imported on the basis of the need in our Country and considering the public health and service
requirements, it is not suitable for the referred import products to be sent to the markets of other
countries by taking them out of the country, and all relevant measures, including barriers via the
system, will be adopted.
I hereby submit for your information and kindly request for the conduct of relevant action.
Dr. Saim KERMAN
President of the Agency