ELIG Gürkaynak Attorneys-at-Law | View firm profile
Turkey
Introduces a New Regulation on Packaging, Inserts and Tracking of
Pharmaceuticals, in line with EU Directives
I – Introduction
On April 25th, 2017, the Ministry of Health
("Ministry") has published the Regulation on Packaging Information, Inserts and
Tracking of Medicinal Products for Human Use ("Regulation") on the Official
Gazette.
Upon publication of the Regulation, the Regulation on
Packaging and Labeling of Human Medicinal Products published on August 12th,
2005 ("Abolished Regulation"), has been abrogated.
The Regulation has been prepared within the scope of
"legislative harmonization", in consideration of the Directive 2001/83/EC on
the Community code relating to medicinal products for human use and Directive 2011/62/EU,
as regards the prevention of the entry into the legal supply chain of falsified
medicinal products.
In a nutshell, the Regulation governs principles as to
the notifications to be made by sellers/importers for tracking of the
distribution chain and includes information required on the packaging and inserts
of medicinal products for human use.
II – Interior, Exterior
Packaging and Directions for Use
– Articles 5 and 6 of the Regulation list the
information required to be added to exterior and interior packaging of human
medicinal products.
– As per Article 5 of the Regulation, in case a
Turkish version of the exterior packaging cannot be prepared, manufacturers
will be allowed to attach a label on the exterior packaging which specifies the
required information listed in Article 5.
– Manufacturers/importers are obliged to include the name
of pharmaceutical in Braille format, as per Article 13. Packaging of pharmaceuticals
should be made complaint with this requirement until 31.12.2018[1].
– Inserts (directions for use) will have to be
prepared as per Article 8 of the Regulation, listing the information indicated
thereunder and in line with the summary of product characteristics and the
relevant guidelines of the Ministry.
– Article 18 lays out the principles on the packaging
of radiopharmaceuticals and the additional information for their directions for
use, such as special precautions, the parts which are not to be used and the
duly disposal of their packages.
III – Marketing Samples
– Principles on the marketing samples of medicinal
products for human use are set forth under Article 10 of the Regulation.
– Products to be used for marketing purposes as per the
Regulation on Promotional Activities of Human Medicinal Products, should also
fulfill the requirements determined by the Regulation.
– Turkish Pharmaceuticals and Medical Devices Institution
("Institution") will determine the products to be excluded from Data Matrix
practice applied to marketing products.
– Data Matrix inserted to the marketing samples should
indicate that the product is for marketing purposes and not for sale.
IV – Tracking of Human
Medicinal Products
– The Regulation, contrary to the Abolished
Regulation, brings an in-depth roundup on the Product Tracking System
("System") of the Institution. Mechanism of the System is described as the
following:
"The System operates based on the principle of
recording of the notifications required to be made by partners who are
identified with a Global Location Number in accordance with their identified
type, to the central data system and the tracking of these. Data Matrix of
human medicinal products is notified to the System by the license/permit
holders. System, upon controlling the uniqueness, standards and content of the
notified Data Matrix records the Data Matrix to data base or rejects those that
are not qualified."[2]
– The Term "partner" used in the foregoing expression has
been described in Article 4 of the Regulation as "Real/legal persons, institutions or organizations that can, limited to
their field of authorization, conduct any operation under human medicinal
products' supply chain such as manufacturing, import, purchasing, sale, usage,
consuming, exportation, assignment, loss, refund."
– Article 15 of the Regulation lists the incidents
that should be notified to the System by partners as well as pharmaceutical
warehouses, such as deactivation process, activities on the registered
pharmaceutical and the cancellation of those.
– Principles on recording and protection of the data
gathered in the System are regulated under Articles 16 and 17 of the
Regulation. Regarding the distribution of human medicinal products, partners
will have to comply with rules set forth under Article 17, which in general
underlines the transport packaging requirements.
V – Transition Process
The Ministry has
granted the following transitional periods for fulfilling the requirements
under the Regulation:
(1) Medicinal products
for human use that are licensed or permitted or subject to license/permit
application before the enforcement of the Regulation will have to be made
compliant with packaging and insert requirements of the Regulation until
September 30th, 2017.
(2) Medicinal products for human use manufactured
before December 31st, 2017 can be preserved with their current
packaging until the expiration of their shelf life.
(3) For medicinal products for human use
manufactured after December 30, 2017, packaging and direction requirements of
the Regulation should be fulfilled.
(4) Foods for special
medical purposes that are not reimbursed but brought under the scope of the Data
Matrix practice as per Article 5 of the Regulation should participate to the Data
Matrix practice latest by December 31st, 2018.
(5) Bulky parenteral,
radiopharmaceuticals and individualized human medicinal products should participate
to the Data Matrix practice (under the scope of guidelines specified in Article
20) latest by December 31st, 2018.
Authors: Gönenç
Gürkaynak Esq., Ceren Yildiz and Ecem Elver, ELIG Attorneys-at-Law
First published in Mondaq
on May 2, 2017
[1]
Provisional Article 2 of the Regulation
[2]
Article 15 of the Regulation