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