6215 Bazı Kanun ve Kanun Hükmünde Kararnamelerde Değişiklik Yapılmasına Dair Kanun
25.04.2017 Beşeri Tıbbi Ürünlerin Ambalaj Bilgileri, Kullanma Talimatı ve Takibi Yönetmeliği_ENG
25 Nisan 2017 TUESDAY Official Gazette Number: 30048
A REGULATION
By Ministry of Health :
Implementing Regulation on the Labeling, Package Leaflet and
Tracing of Human Medicinal Products
SECTION ONE
Objective, Scope, Legal Basis and Definitions
Objective
ARTICLE 1- (1) The objective of this Implementing Regulation is to set the procedures and
principles regarding the information which must be available on labeling, package leaflet of authorized
or permitted human medicinal products and allow more effective efforts against defective and falsified
human medicinal products by tracing and registration system in supply chain to handle public safety.
Scope
ARTICLE 2- (1) This Implementing Regulation shall comprise the minimum compulsory
information that must be placed on the labeling, package leaflet and also the real persons and legal
entities and institutions and organizations that are in supply chain of human medicinal products and
responsible for making compulsory notifications throughout the chain.
Legal Basis
ARTICLE 3- (1) This Implementing Regulation has been prepared on the basis of Law No.
1262 on Pharmaceutical and Medicinal Preparations, dated 14 May 1928, clause (k) of paragraph one
in article 3 of Principal Law No. 3359 on Health Services, dated 7/5/1987 and article 24 of Law No.
6197 on Pharmacies and Pharmacists, dated 18 December 1953 and article 27 of Decree-Law No. 663
on Organization and Duties of Ministry of Health and its Affiliated Agencies dated 11 October 2011.
Definitions
ARTICLE 4- (1) For the purposes of this Implementing Regulation, the following definitions
shall apply:
a) Labelling: Information on the immediate or outer packaging.
b) Human medicinal product:
- Any substance or combination of substances presented as having properties for treating or preventing disease in human beings or,
- Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis, c) Name of the human medicinal product: The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorization holder, ç) Strength of the human medicinal product: The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form, d) Notification: Process of inputting actual movement and state of each unit of human medicinal product into Pharmaceutical Track and Trace System through related stakeholders, e) Outer packaging: The packaging into which is placed the immediate packaging,
f) Active substance: Any substance or mixture of substances intended to be used in the
manufacture of a medicinal product and that, when used in its production, becomes an active ingredient
of that product intended to exert a pharmacological, immunological or metabolic action with a view to
restoring, correcting or modifying physiological functions or to make a medical diagnosis,
g) Pharmaceutical form: The presentation form of the human medicinal product manufactured
according to its purpose of use,
ğ) Global location number: The descriptive used for individualization of stakeholders who are
in Pharmaceutical Track and Trace System,
h) Readable information: Descriptive content information placed under or near the descriptive
to present contents of barcode and data matrix for end user,
ı) Immediate packaging: The container or other form of packaging immediately in contact with
the medicinal product.
i) Pharmaceutical Track and Trace System: Central register and tracking system which enables
the individualization of human medicinal products by data matrix, to track all processes such as
production, importation, exportation, purchasing, sale, transfer, consumption, loss and reimbursement
of each human medicinal product in the supply chain and also recalling and blocking transactions can
be made through this system,
j) Data matrix: Two-dimensional code in data matrix type that provides the individualization of
each human medicinal product as a safety feature,
k) Summary of product characteristics: Written information about human medicinal product
prepared for health professionals,
l) Kit: Any preparation to be reconstituted or combined with radionuclides in order to get
finished radiopharmaceutical, usually prior to administration,
m) Package leaflet: A leaflet containing information prepared for the user which accompanies
the human medicinal product,
n) Agency: Turkish Medicines and Medical Devices Agency,
o) Global Trade Item Number (GTIN): GTIN is the number which is included in the barcode of
commercial products and defines each package size belonging to the name of human medicinal product
based on marketing authorization or permission and identifies the product type around the world as
unique,
ö) Licensor company;
- The company which authorizes the real persons or legal entities for the importation of human medicinal products to Turkey, getting marketing authorization and marketing of them or,
- The company which authorizes the real persons or legal entities for manufacturing, getting
marketing authorization and marketing of licensed manufactured human medicinal products in Turkey,
p) Dose delivery device: Devices which are used for measurement according to posology
mentioned in package leaflet like measuring spoons, measuring cups, droppers, cylindrical measuring
spoons, oral dosing syringes,
r) Package transfer system: An application having information of data matrix and hierarchical transfer of packs of medicinal products through stakeholders,
s) Batch number (or Lot number): A distinctive combination of numbers and/or letters which specifically identifies the defined quantity of a product produced in one cycle of processes so that it could be expected to be homogeneous,
ş) Stakeholder: Real persons or legal entities or institutions or organizations who are authorized to perform any transaction in supply chain such as manufacturing, importation, exportation, purchasing, sale, using, overturn, consumption, loss and reimbursement related to the human medicinal product although it is limited to the authorized areas, t) Radiopharmaceutical: Any medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose, u) Radionuclide: Core undergoes spontaneous degradation, or radioactive characterized atom emitting more ionizing radiation, ü) Radionuclide generator: Any system incorporating a fixed parent radionuclide from which a daughter radionuclide is produced through elution or by any other method and used in radiopharmaceuticals, v) Radionuclide precursor: Any other radionuclide produced for the radio-labelling of another substance prior to administration, y) Marketing authorization or permission holder: The real persons or legal entities who have the marketing authorization or permission of manufacturing or importing of human medicinal products, z) Falsified human medicinal product: With the exception of unintentional quality defects and without prejudice to infringements of intellectual property rights, any medicinal product with a false representation of:
- its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; or
- its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorization holder; or
- its history, including the records and documents relating to the distribution channels used,
aa) Consumption centers: Real persons or legal entities or institutions or organizations who do
not have the right of selling human medicinal products but only holding them in stock,
bb) Serial Number - SN: It is the number used in order to identify each unit of the product identified with GTIN,
cc) The expiry date: It shows until when the human medicinal product can be used safely, çç) International non-proprietary name (INN): The international name of an active substance, accepted or recommended by the World Health Organization, that does not have international proprietorship and should not be used in brand registration in line with the rules of the World Health Organization, dd) Excipient: Any constituent of a human medicinal product other than the active substance and the packaging material, ee) Common name: The international non-proprietary name (INN) recommended by the World Health Organization, or, if INN does not exist, the common name which is available in scientifically approved classical references, ff) High-risk human medicinal product: Human medicinal products which create irrevocable or permanent negative effect on patient when misused.
SECTION TWO Outer Packaging, Immediate Packaging and Package Leaflet
Outer packaging
ARTICLE 5- (1) The following particulars shall appear on the outer packaging of medicinal
products or, where there is no outer packaging, on the immediate packaging:
a) The name of the human medicinal product followed by its strength and pharmaceutical form,
and, if appropriate, whether it is intended for babies, children or adults; accepted by the Agency based
on marketing authorization or permission. Where the product contains up to three active substances, the
common name shall be included,
b) A statement of the active substances expressed qualitatively and quantitatively per dosage
unit or according to the form of administration for a given volume or weight, using their common names,
c) The pharmaceutical form and the contents by weight, by volume or by number of doses of
the product,
ç) A list of those excipients known to have a recognized action or effect and included in the
detailed guidance published pursuant to paragraph 1 of article 20. However, if the human medicinal
product is injectable, or a topical or eye preparation, all excipients must be stated,
d) The method of administration and, if necessary, the route of administration. Space shall be
provided for the prescribed dose to be indicated,
e) The special warning stating: “Keep in its package, in a place stored out of the reach and sight
of children” is included,
f) The warnings: “Do not purchase packages that have been cut or opened”, “Read the package
leaflet before use”, “Consult your doctor if any undesirable effects appear” shall be included,
g) A special warning, if this is necessary for the medicinal product,
ğ) The storage conditions, and if any, the special storage conditions of the product will be
indicated,
h) Special precautions relating to the disposal of unused human medicinal products or wastes of
them and where necessary, the appropriate collection system shall be indicated,
ı) The symbol of recyclable package, the number and abbreviation of the type of package shall
be indicated on the packages as per the Implementing Regulation on Packaging and Package Wastes
published in the Official Gazette No. 28035 dated 24 August 2011. The management of the wastes of
outer packages shall be conducted within the scope of the related Implementing Regulation,
i) The name and address of the marketing authorization holder or permission holder, where
applicable, the logo of the marketing authorization holder or of the licensor company shall be indicated,
j) The name and address of the manufacturing site shall be indicated,
k) The marketing authorization / permission date and number of the human medicinal product
will be indicated,
l) The batch number shall be indicated. If batch number is placed in readable codes near data
matrix it may not be placed on other areas of outer package for the second time,
m) The expiry date shall be indicated. If the expiry date is near data matrix in readable codes
there is no need to mention again on outer package for the second time. If the expiry date take place on
outer package other than data matrix, the date must be compatible with the date stated in the data matrix,
n) The data matrix and the readable information relating to the content of this data matrix shall
be available on the outer package to ensure tracking of human medicinal products. Marketing
authorization or permission holders shall place readable information regarding data matrix and its
content on outer packages of human medicinal products with manufacturing or importing authorization
in line with the standards in guidelines stated in the first paragraph of article 20 of this Implementing
Regulation. The data matrix shall be on the packages of human medicinal products subject to
prescription or of non-prescription products and of special nutritional medicinal products including
those with hospital packages. Radiopharmaceuticals, large volume parenterals and personalized human
medicinal products are out of the scope of implementing data matrix on outer package,
o) The barcode of the medicinal product may be included,
ö) The price of the medicinal product may be indicated,
p) A statement indicating whether the medicinal product is or is not subjected to a prescription
shall be included,
r) The statement “It contains dose delivery devices” is indicated for measurement purpose. If
the volume of dose delivery device is different from measurement volume, then they are stated
separately.
(2) If outer packaging cannot be prepared in Turkish, a Turkish label containing information
stated in the first paragraph of this article is attached,
(3) High-risk human medicinal products may contain markings on outer packaging stating that
these are high-risk products.
Immediate Packaging
ARTICLE 6- (1) Except for the particulars indicated in clauses (a), (b) and (c) of paragraph
two of this article and clauses (f), (n), (o) and (p) of paragraph one of article 5 of this Implementing
Regulation, immediate packaging shall bear the properties and information indicated in the first
paragraph of article 5 of this Implementing Regulation.
(2) Provided that it can be in accordance with the provisions of the paragraph one of this article,
particularly;
a) The following particulars at least shall appear on immediate packaging in the form of blister
packs which have outer packaging including requirements on packaging information laid down in
articles 5 and 9 of this Implementing Regulation:
- The name of the human medicinal product as laid down in clause (a) of the paragraph one of article 5 of this Implementing Regulation,
- The name or logo of the marketing authorization holder/permission holder,
- The expiry date written in accordance with the date in readable codes near data matrix,
- The batch number. b) The following particulars at least shall appear on small immediate packaging on which the particulars laid down in the first paragraphs of articles 5 and 9 of this Implementing Regulation cannot be displayed:
- The name of the human medicinal product as laid down in clause (a) of the paragraph one of article 5 of this Implementing Regulation and if necessary, the route of administration,
- The method of administration,
- The expiry date written in accordance with the date in readable codes near data matrix,
- The batch number,
- The contents by weight, by volume or by unit.
c) The name or logo of the marketing authorization holder/permission holder shall appear, if
possible, on small immediate packaging on which the particulars laid down in the first paragraphs of
articles 5 and 9 cannot be displayed.
(3) The current packaging of the human medicinal products with no outer packaging should
comply with article 5 of this Implementing Regulation.
(4) The human medicinal product has an outer packaging prepared in accordance with article 5
of this Implementing Regulation can be accepted only if, an immediate packaging in Turkish cannot be
prepared,
(5) The expiry date in immediate packaging must be in accordance with the date in readable
codes near data matrix,
(6) Blister immediate packaging which have outer packaging that includes the requirements
determined in terms of packaging information in articles 5 and 9 of this Implementing Regulation may
be produced in a form that equals to each dosage unit in its content and that includes name, expiry date
and batch number of human medicinal product.
(7) High-risk human medicinal products may contain markings on immediate packaging stating
that these are high-risk products.
Transparent outer packages
ARTICLE 7 – (1) If the information needed to appear on outer packaging cannot be displayed
on transparent outer packaging, it must be available on immediate packaging.
Package leaflet
ARTICLE 8- (1) The package leaflet shall be drawn up in accordance with the summary of the
product characteristics of human medicinal product; to be understood easily by the users and shall
include information stated below and be prepared in line with guidelines stated in article 20 of this
Implementing Regulation,
a) For the identification of human medicinal product:
-
The name of human medicinal product including its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults, accepted by the Agency for marketing authorization or permission shall be written.
-
The active substances and excipients contained in each dosage unit of human medicinal product or the active substances contained in the specific volume or weight of the product according to the route of administration are stated qualitatively and the active substances are expressed quantitatively using their common name.
-
The pharmaceutical form and content by weight, by volume or by dosage units of the human medicinal product shall be indicated.
-
The pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient shall be indicated. b) The therapeutic indications shall be indicated. c) The list of information below which is necessary before the medicinal product is taken:
-
Contra-indications;
-
Appropriate precautions for use;
-
Forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;
-
Warnings for special patient groups such as children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions,
-
Possible effects on the ability to drive vehicles or to operate machinery,
-
Special warnings on excipients which are important for the safe and effective use of the medicinal product, shall be indicated. ç) The necessary and usual instructions for proper use of the human medicinal product, and in particular:
-
The dosage,
-
The method and, if necessary, route of administration,
-
The frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered, shall be indicated. d) Depending on the nature of the human medicinal product:
-
The duration of treatment, where it should be limited;
-
Symptoms to be met, precautions to be taken and necessary emergency procedures in case of overdose;
-
What to do when one or more doses have not been taken;
-
Indication, if necessary, of the risk of withdrawal effects; shall be indicated. e) A description of the adverse reactions which may occur under normal use of human medicinal product and, if necessary, the action to be taken in such a case and a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product if any adverse reaction, which is stated or not in the package leaflet, occur shall be indicated. f) With a reference to that the expiry date is available on the packaging information;
-
A warning against the use of the product after that date;
-
The storage conditions,
-
If necessary, a warning against certain visible signs of deterioration or any change in the product;
-
The name and address of the marketing authorization or permission holder,
-
The name and address of the manufacturing place, shall be indicated. g) The date on which the package leaflet was last revised shall be stated. ğ) Requirements about packaging information stated in “The Implementing Regulation on Safety of Medicinal Products” which was published in the Official Gazette No: 28973 dated 15 April 2014 shall be indicated.
(2) The package leaflet shall be legible and clear.
(3) When animal sources are used in the active substances and excipients of human medicinal
product, this source shall be indicated in the package leaflet in accordance with the guidelines stated in
paragraph one of article 20 of this Implementing Regulation.
(4) Package leaflet can be prepared in formats appropriate for the blind and partially-sighted
persons under suitable circumstances.
Symbols and other information
ARTICLE 9 – (1) The outer packaging and the package leaflet may include symbols or
pictograms designed to clarify certain information mentioned in articles 5 and 8 of this Implementing
Regulation and other information compatible with the summary of the product characteristics which is
useful to the patient, provided that these symbols do not have any promotional nature.
(2) The detailed particulars relating to the symbols, pictograms and information mentioned in
paragraph one of this article shall be arranged with the guidance indicated in paragraph one of article 20
of this Implementing Regulation.
Information on promotional samples
ARTICLE 10 – (1) According to the provisions of Implementing Regulation on the
Promotional Activities of Human Medicinal Products published in the Official Gazette No. 29405 dated
3 July 2015 must comply with the requirements determined by this Implementing Regulation. However,
the products which are not obliged to bear data matrix on promotional samples will be decided by the
Agency. The data matrix on promotional samples shows that these products cannot be sold.
(2) A promotional sample must have a statement on its outer package as “This is a promotional
sample, it cannot be sold.” using the widest surface of the outer package. If possible, the same statements
can be used on the immediate package also.
Solvents
ARTICLE 11 – (1) Also the products which are placed on the market as a solvent alone or to
be used with another human medicinal product shall comply with the provisions of this Implementing
Regulation. Regarding solvents which are presented in the same package with any human medicinal
product, the name and/or formula of the solvent and its net content shall be indicated on the outer
package and the package leaflet.
Products with a restricted period of use
ARTICLE 12 – (1) The duration of use and storage conditions of products with a restricted
period upon being reconstituted, diluted or opened shall be separately indicated on the package and
package leaflet.
Other conditions relating to packaging
ARTICLE 13 — (1) Human medicinal products shall be presented with package leaflet. The
package leaflet can be conveyed in the outer packaging or on the immediate packaging or on the outer
packaging.
(2) It is obligatory that the information relating to the labelling and the package leaflet shall be
in Turkish for the product to be marketed. However, where necessary and if desired, the particulars
stated in paragraph one of articles 5, 8 and 9 of this Implementing Regulation shall appear in Turkish
and also in one of the official languages of the European Union member states with the approval of the
Agency and on condition that all information in used languages will be same.
(3) The particulars referred to in the first paragraphs of articles 5 and 9 and the paragraphs 1 and
2 of article 6 of this Implementing Regulation shall be easily legible, clearly comprehensible and
indelible.
(4) The name of the human medicinal product, as referred to in clause (a) of the paragraph one
of article 5 shall also be expressed in Braille format on the outer packaging.
(5) Any approval shall not be necessary for the applications made by marketing authorization
holder with a commitment which states that there would not be any change in outer packaging of
authorized or permitted products which need renewal pursuant to fourth paragraph of this article.
(6) On the package information of non-prescription human medicinal products there may be
special information belonging to user in the form identified in the guidelines stated in the first paragraph
of article 20 of this Implementing Regulation.
Application
ARTICLE 14- (1) In the marketing authorization or permission applications, two samples or
draft mock-ups of the outer packaging and the immediate packaging of a medicinal product, together
with the draft package leaflet, shall be submitted to the Agency by the applicant.
(2) The Agency shall require from the applicant to complete the missing information and the
required documents in the premarketing authorization process if the packaging information or the
package leaflet or the information in the summary of product characteristic of the human medicinal
product are incompatible with each other. If the deficiencies are not submitted by the applicant within
one year, or if no action is taken within this period, the file is returned to applicant.
(3) Information that does not take place in summary of product characteristics, however
available in labelling and package leaflet shall be submitted to Agency. If Agency have not replied a
proposed change within 90 days following the submission of the application, the applicant may put the
change into effect. If the implemented change is contrary to the Implementing Regulation and
ascertained by the Agency the situation is informed to the applicant. Even if the Agency does not respond
to the change to be carried out in labeling and package leaflet, this does not put up the legal responsibility
of manufacturer or if necessary, marketing authorization or permission holder.
(4) Marketing authorization or permission holders or the applicant shall commit that outer
packages of human medicinal products are designed in such a way to prevent the risk of mix up with
outer packages of human medicinal products already authorized or permitted by the Agency.
SECTION THREE
Tracing of Human Medicinal Products
The Pharmaceuticals Track and Trace System
ARTICLE 15- (1) The Pharmaceuticals Track and Trace System depends basically on the
follow-up of notifications that the stakeholders identified by the Global Location Number are obliged
to perform according to the types they have defined by being recorded in the central data system. The
data matrix of human medicinal products are notified to the Pharmaceuticals Track and Trace System
by the marketing authorization or permission holder. The Pharmaceuticals Track and Trace System
checks the individualization, standards and content of the reported data matrix, records the appropriate
ones in the database and rejects those that are not appropriate.
(2) Stakeholders must notify the following information to the Pharmaceuticals Track and Trace
System:
a) Marketing authorization or permission holders are obliged and authorized to register each
unit of their products to the Pharmaceuticals Track and Trace System with production and importation
notification and also make notification for purchase, sale, return, sale cancellation, exportation,
exportation cancellation, overturn of the product, cancellation of overturn of the product etc. and
deactivation steps of the human medicinal products for expiry date, stealing, decomposition etc.
b) Warehouses and companies authorized to make exportation are obliged to make notification
to the System, for purchase, sale, return, sale cancellation, exportation, exportation cancellation,
overturn of the product, cancellation of overturn of the product etc. and deactivation steps of the human
medicinal products for expiry date, stealing, decomposition etc.
c) Retail pharmacies are obliged to make notification to the System, for purchase, sale, return,
overturn of the product, cancellation of overturn of the product etc. and deactivation steps of the human
medicinal products for expiry date, stealing, decomposition etc.
ç) Consumption centers are obliged to make notification to the System, for purchase, return,
consumption, overturn of the product, cancellation of overturn of the product etc. and deactivation steps
of the human medicinal products for expiry date, stealing, decomposition etc.
d) Public or private reimbursement agencies are obliged to make notification of human
medicinal products they paid on to the Pharmaceutical Trace and Track System with sale query
notification.
(3) Stakeholders are obliged to notify all the activities and transactions cancellations carried out
on the products of which data matrix is registered to data base to the Pharmaceutical Track and Trace
System. The Pharmaceutical Track and Trace System control the transactions and confirm the
convenient ones, refuse the inconvenient ones.
(4) Stakeholders are obliged to store the written documentation of transactions such as
production and importation documents, bill of sale, receiving note, prescription which shall verify the
notification they made by hard copy or electronically for five years and obliged to submit whenever it
is required by the Agency.
(5) When warehouses identify as falsified or suspect to be falsified about large volume
parenterals, radiopharmaceuticals and personalized medicines which are not subject to the
Pharmaceutical Track and Trace System, they must immediately inform the Agency and if applicable,
the marketing authorization holder. When they identify that the human medicinal products subjected to
notification as part of the Pharmaceutical Track and Trace System has not been notified to the System,
they must immediately inform the Agency and where possible, the marketing authorization holder.
Registration and safety
ARTICLE 16- (1) The transactions registration of human medicinal products are carried out by
data matrix and transactions registration of stakeholders are conducted by global location number. The
registration information is stored in Ministry of Health’s Database Center.
(2) The data matrix is consist of Global Trade Item Number, batch (lot) number, serial number
and the expiry date. Global Trade Item Number and the serial number make the product individualized.
The Pharmaceutical Track and Trace System does not allow registration of the product having same
global trade item number and serial number.
Distribution
ARTICLE 17- (1) In distribution of each human medicinal product, it is obligatory to comply
with the provisions of this Implementing Regulation. However, medicinal products in public
procurement can bear extra information like “subject to procurement and cannot be sold” provided that
it does not contrary to this Implementing Regulation.
(2)When transporting more than one box of human medicinal products, marketing authorization
or permission holders shall use “transport packaging” for the safety of these products. Transport
packaging can be one within the other as package, parcel, box or bag. The content of transport packaging
as numbers must be determined reasonably during the sale till the last point of consumption without
opening.
(3) Transport packaging must bear an identifier containing information about this package or
identifier carrying all data matrix information of human medicinal products in these packages. Identifiers
which are available on transport packaging are implemented in conformity with the guidelines stated in
first paragraph of article 20 of this Implementing Regulation. The stakeholders can use Package Transfer
System in order to transfer these identifiers among each other.
(4) When there is a data matrix usage difficulty due to the packaging characteristics of human
medicinal products, the transport packaging of human medicinal products of more than one box can be
sold together, is data matrixed by one code.
(5) Track system rules for large volume parenterals, radiopharmaceuticals and personalized
medicines shall be applied according to guidelines stated in the first paragraph of article 20 of this
Implementing Regulation.
SECTION FOUR
Radiopharmaceuticals
Labeling for radiopharmaceuticals
ARTICLE 18- (1) The outer packaging and the container of human medicinal products
containing radionuclides shall be labelled in accordance with the related legislation of Turkish Atomic
Energy Authority and other international legislations. Moreover, the labelling shall comply with the
provisions set out in paragraphs 2 and 3 of this article.
(2) The label on the shielding shall include the particulars mentioned in article 5 except for the
provisions of clauses (n) and (p) of the paragraph one of article 5 of this Implementing Regulation. In
addition, the labelling on the shielding shall explain in full the coding used on the vial and shall indicate
the radioactivity marker, for a given time and date, the amount of radioactivity per dose or per vial and
the number of capsules, or, for liquids, the number of milliliters in the container.
(3) The vial shall be labelled with the following information:
a) The name or code of the medicinal product, including the name or chemical symbol of the
radionuclide,
b) The batch number and expiry date,
c) The international symbol for radioactivity,
ç) The name and address of the manufacturer,
d) The amount of radioactivity as specified in paragraph 2 of this article.
Package leaflet of radiopharmaceuticals
ARTICLE 19- (1) It is mandatory for the packaging of radiopharmaceuticals, radionuclide
generators, radionuclide kits or radionuclide precursors to include a detailed instruction leaflet.
(2) The package leaflet shall be established in accordance with the provisions of article 8 of this
Implementing Regulation. In addition, the leaflet shall include any precautions to be taken by the user
and the patient during the preparation and administration of the medicinal product and special
precautions for the disposal of the packaging and its unused contents.
SECTION FIVE
Miscellaneous and Final Provisions
Guidance
ARTICLE 20- (1) The Agency shall publish in the form of a guidance the general principles to
be complied with where necessary and in relation with the following;
a) The wording of certain special warnings for certain categories of human medicinal products;
b) The particular information needs for the users relating to non-prescription human medicinal
products;
c) The legibility of particulars on the labelling and package leaflet;
ç) The application methods for the Pharmaceutical Track and Trace System,
d) The list of excipients which must feature on the labelling of human medicinal products and
the way in which these excipients must be indicated;
(2) The Agency may issue supplementary guidelines or notifications relating to the enforcement
of this Implementing Regulation for conditions not indicated in the Implementing Regulation and where
deemed necessary.
Price label and barcode
ARTICLE 21- (1) As the data matrix applied on the labeling of all products manufactured since
1 January 2010 by the marketing authorization or permission holders are used for reimbursement and
monitoring purposes, data matrix statement compromise both price label and barcode in other
legislations referring to this Implementing Regulation.
Penalty provisions and precautions
ARTICLE 22 – (1) For those who fail to act in accordance with the provisions of this
Implementing Regulation, Law No. 1262 on Pharmaceutical and Medicinal Preparations, Law on
Pharmacies and Pharmacists No.6197, the Misdemeanor Law dated 30 March 2005 No.5326 and the
provisions of Turkish Penal Code, No. 5237, dated 26 September 2004 shall be applied.
(2) Furthermore, in case of detection of violation of the provisions of this Implementing
Regulation, the measures and sanctions envisaged by the Implementing Regulation on Regarding the
Marketing Authorization to Human Medicinal Products published in the Official Gazette dated 19
January 2005, No. 25705 shall be applied.
References
ARTICLE 23 – (1) References made to Implementing Regulation on Packaging and Labeling
of Human Medicinal Products which has been abolished by article 25 are deemed referred to this
Implementing Regulation.
European Union legislation harmonization
ARTICLE 24- (1) This Implementing Regulation has been prepared in line with Directive
2001/83/EC on medicinal products for human use and 2011/62/EU on relating to medicinal products for
human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal
products, for the purpose of ensuring harmonization with the relevant legislation of the European Union
regarding medicinal products for human use.
Abolished regulation
ARTICLE 25 – (1) The Implementing Regulation on the Packaging and Labeling of Human
Medicinal Products published in the Official Gazette dated 12 August 2005, No. 25904, has been
abolished.
Transition provision
TEMPORARY ARTICLE 1 – (1) Packages and leaflets of current human medicinal products
of which marketing authorization or permission application have been made or which were authorized
or permitted before the entry into force of this Implementing Regulation, shall be submitted to the
Agency in line with the provisions of this Implementing Regulation until 30 September 2017 at the
latest.
(2) Human medicinal products manufactured before 31 December 2017 may be available on the
market with current packages until expiry date.
(3) Packages and leaflets of human medicinal products manufactured after 30 December 2017
are obliged to meet provisions of this Implementing Regulation.
(4) Food for special medical purposes which are not subject to reimbursement and included in
the data matrix according to clause (n) of paragraph 1 of article 5 of this Implementing Regulation, the
date of transfer to data matrix application is 31 December 2018 at the latest.
(5) The date of transfer to data matrix application within the scope of guidelines stated in the
first paragraph of article 20 of this Implementing Regulation for large volume parenterals,
radiopharmaceuticals and personalized medicines is 31 December 2018 at the latest.
Braille format implementation
TEMPORARY ARTICLE 2 – Requirements stated in the fourth paragraph of article 13 shall
be met until 31 December 2018.
Entry into force
ARTICLE 26 – (1) This Implementing Regulation shall enter into force when published.
Enforcement
ARTICLE 27 – (1) The provisions of this Implementing Regulation shall be enforced by the
President of Turkish Medicines and Medical Devices Agency.