Healthcare & Life Sciences Newsletter

The Turkish Pharmaceuticals and Medical Devices Authority
(“TITCK“) recently published an
announcement regarding European Union (EU) Regulation No. 2017/745,
Regulation on Marketing Authorization of Foods for Special Medical
Purposes and Regulation on Marketing Authorization of Traditional
Herbal Medicinal Products. Moreover, the TITCK has amended the
Guideline on Early Access Programs for Pharmaceuticals, the
Guideline on Marketing Authorization Renewal for Medicinal Products
for Human Use and announced the Fourth Quarter Results on Market
Surveillance and Inspection of Cosmetics and Biocidal Products.

EU Regulation No. 2017/745

On 16 January 2023, the TITCK published an announcement on the
proposed regulation amending the transitional clause of EU
Regulation 2017/745 (“Regulation“) for
reducing the risk of nonavailability of medical devices.

Article 120 of the Regulation, which regulates the transitional
period, needs to be extended for various reasons, such as the fact
that small and medium-sized enterprises are not sufficiently
prepared to meet the new requirements, the high risk that many
devices will not be certified before the end of the transitional
period, and problems in the supply of medical devices within the
EU.

In this regard, on 6 January 2023, the European Commission
submitted and opened for public consultation a Proposal for a
Regulation amending the relevant Article 120. Accordingly, for
medical devices covered by a certificate issued by a notified body
pursuant to Directive 90/385/EEC and Directive 93/42/ EEC as of 25
May 2017 and valid as of 26 May 2021, and for devices covered by a
declaration of conformity issued under Directive 93/42/EEC before
26 May 2021 and for which the conformity assessment procedure under
the Regulation requires the involvement of a notified body, 26 May
2024 is the latest date for placing on the market. This will be
extended until the following dates for each category.

  • 26 May 2026 for Class III custom-made implantable devices,

  • 31 December 2027 for high-risk (Class III) devices,

  • 31 December 2028 for low- and medium-risk devices (other Class
    IIb devices, Class IIa devices and Class I devices placed on the
    market in sterile condition or with a measuring function)

The Announcement is available here (in Turkish)

Guideline on Early Access Programs for Pharmaceuticals

On 19 January 2023, the TITCK updated the Guideline on Early
Access Programs for Pharmaceuticals. The Guideline sets out the
principles and procedures for the procurement of medicinal products
that do not have a marketing authorization in Türkiye, but
that have (or do not have) a marketing authorization in other
countries, for patients who have been unsuccessful with standard
treatment methods and medicinal products that have marketing
authorization in Türkiye, or patients who are no longer able
to receive such treatments. In this regard, the Guideline includes
various regulations such as the patients to be included in the
program, the execution of the program, application stages,
documents required for application, adverse event notification and
termination of the program.

The Guideline is available here (in Turkish).

Fourth Quarter Results on Market Surveillance and Inspection of
Cosmetics and Biocidal Products

On 23 January 2023, the TITCK announced the results of its
cosmetics sector market surveillance and inspection conducted in
October, November and December 2022.

Of the 203 cosmetic products inspected by the TITCK’s
Cosmetics Supervision Department, 162 were noncompliant and 16 were
unsafe. The responsible companies were subject to an overall
administrative fine of TRY 545,340 (approximately USD 28,910).

Of the 10 type 1 and type 19 biocidal products inspected by the
TITCK’s Cosmetics Supervision Department, 5 were unlicensed and
1 was unsafe. The responsible companies were subject to an overall
administrative fine of TRY 241,720 (approximately USD 12,814).

The 2022 fourth quarter results for cosmetic products are
available here (in Turkish).

The type 1 and type 19 biocidal products’ third quarter
results of 2022 are available here (in Turkish).

What Do the Results Say?

The cosmetic products’ safety results reveal that there has
been a decrease in the number of inspected products and
noncompliant products. In this regard, the total amount of
administrative fines has decreased compared to the results for the
third quarter of 2022.

The type 1 and type 19 biocidal products’ safety results
reveal that there has been a decrease in the number of inspected,
unlicensed and unsafe products. Accordingly, there is also a
significant decrease in the total amount of administrative
fines.

Regulation on Marketing Authorization of Foods for Special
Medical Purposes

On 28 January 2023, the TITCK published the Regulation on
Marketing Authorization of Foods for Special Medical Purposes,
effective as of 1 July 2023. The Regulation sets out various issues
such as classification, marketing authorization and packaging of
foods for special medical purposes. The main amendments introduced
by the Regulation are as follows:

  • For foods for special medicinal purposes to be placed on the
    market, the TITCK must issue a marketing authorization. In
    addition, a sales authorization is also required for foods for
    special medicinal purposes to be placed on the market for the first
    time.

  • Foods for special medical purposes are classified into three
    groups: i) containing standard nutrients; ii) containing nutrients
    developed specifically for a disease or health problem, which may
    constitute the sole source of nutrition for the user when used in
    accordance with the manufacturer’s instructions; and iii)
    nutritionally incomplete products that are not suitable for use as
    a sole source of nutrition, either standard formulated products or
    products whose nutrient content is tailored to a disease or health
    problem.

  • Only vitamins, minerals, amino acids, other nitrogen containing
    compounds and other nutrients can be used to meet the nutrient
    requirements in the production of food for special medical
    purposes.

  • Foods for special medical purposes developed to meet the
    nutritional requirements of infants and young children must not
    contain pesticide residues exceeding 0.01 mg/kg per active
    ingredient.

  • Foods for special medical purposes must be packaged and the
    phrase “Food for Special Medical Purposes”
    (tr.”Özel Tibbi Amaçli Gida”) must
    be added to the packaging. In addition, the information specified
    in the Regulation must be included on the packaging. Besides, the
    packaging of foods for special medical purposes developed to meet
    the nutritional needs of infants must not contain any elements,
    including pictures of babies, any photographs, figures and pictures
    that encourage the use of the product.

  • For products that are within the scope of the relevant
    regulation but have been approved by the TITCK before the
    publication of the regulation and for which import or manufacturing
    permits have been issued and placed on the market in this way,
    marketing authorization must be applied for from the TITCK by 31
    December 2025 at the latest. Until then, products can be placed on
    the market based on existing authorizations. However, if a
    marketing authorization is not issued within 1 year from the date
    of application, the existing authorizations will be deemed
    invalid.

The Regulation is available here (in Turkish)

Regulation on Marketing Authorization of Traditional Herbal
Medicinal Products

On 3 February 2023, the Regulation on Marketing Authorization of
Traditional Herbal Medicinal Products entered into force through
its publication. It regulates various issues such as the marketing
authorization of traditional herbal medicinal products and
obtaining a sales permit. The main amendments introduced by the
Regulation are as follows:

  • Natural or legal persons residing in Türkiye must apply to
    the TITCK for a marketing authorization to place a traditional
    herbal medicinal product on the market. In addition, a sales
    authorization must be obtained for the traditional herbal medicinal
    product to be put on the market for the first time.

  • Traditional herbal medicinal products for which a marketing
    authorization application will be made must: i) be designed for use
    without a prescription for diagnosis or treatment without medical
    supervision of a doctor and have appropriate indications specific
    to traditional herbal medicinal products in terms of composition
    and intended use; ii) be prepared only for specific uses in
    accordance with a specific efficacy and posology; iii) be a
    medicinal product for human use for oral, externally imposed or
    inhaled use; and iv) the traditional use must be proven by
    bibliographic data.

  • Natural persons wishing to obtain a marketing authorization
    must have graduated from a higher education institution in
    pharmacy, medicine or chemistry and be authorized to practice their
    profession in Türkiye; legal entities must employ a person
    with these qualifications as an “authorized person”

  • In issuing a marketing authorization, the TITCK considers that
    quality is demonstrated by appropriate technological and
    pharmaceutical qualities and that efficacy and safety under
    conventional conditions of use have been proven.

  • The marketing authorizations issued for traditional herbal
    medicinal products by the TITCK will continue to be valid provided
    that the holder fulfills its responsibilities under the
    Regulation.

The Regulation is available here (in Turkish).

Guideline on Marketing Authorization Renewal for Medicinal
Products for Human Use

On 7 February 2023, the TITCK updated the Guideline on Marketing
Authorization Renewal for Medicinal Products for Human Use. In this
regard, amendments have been introduced for products that have an
annotation stating that the validity of the marketing authorization
has been “extended for 5 years”. The main amendments
introduced by the Guideline are as follows:

  • For products with an annotation on the marketing authorization
    stating that the validity of the marketing authorization has been
    “extended for 5 years”, i) a letter of approval regarding
    the currency of the short product information/ instructions for
    use, ii) a letter of approval regarding the comprehensive quality
    summary issued by the Technological Evaluation Unit for Marketing
    Authorized Products or the Biological and Biotechnological Products
    Unit, and iii) a letter of approval for the periodic benefit risk
    assessment report issued by the Pharmacovigilance Risk Management
    Unit of the TITCK are not required for marketing authorization
    renewal applications to be submitted for the revision of
    “scientific review results have been found appropriate and the
    marketing authorization remains valid”.

The Guideline is available here (in Turkish).

Conclusion

The TITCK continues to provide guidance for companies working in
the healthcare industry. Companies should carefully review the
TITCK’s announcements and take necessary actions to ensure
compliance.

To view the full article, click here.

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.

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