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1

WHAT ARE STRICTLY CONTROLLED CONDITIONS UNDER KKDİK REGULATION AND WHAT DO THEY REQUIRE?

13-06-2025

According to Articles 17 and 18 of the KKDİK Regulation (Turkish REACH), the registration of substances as on-site isolated intermediates or transported isolated intermediates requ
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2

ENGLISH VERSION OF THE KKDİK REGULATION NO. 30105

13-06-2025

The KKDİK Regulation No. 30105, which was enacted regarding the Registration, Evaluation, Authorization, and Restriction of Chemicals in Turkey, serves as a significant refe
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3

STEPS TO ACCESS THE CHEMICAL REGISTRATION SYSTEM (KKS)

13-06-2025

Integrated Environmental Information System (EÇBS) is an application integrated with e-government and affiliated to the Ministry of Environment, Urbanization and Clim
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4

WHAT IS OBLIGATIONS OF TOLL MANUFACTURERS UNDER THE KKDIK REGULATION?

13-06-2025

The KKDIK (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation, which was implemented in Turkey for the safe use and control of chemicals, imposes reg
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5

KKDIK REGISTRATION OBLIGATION FOR POLYMERS AND THE STATUS OF MONOMERS

13-06-2025

The KKDİK (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation has introduced comprehensive regulations to ensure the safe use of chemicals. However, there is a specia
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6

WHAT IS THE STATUS OF SUBSTANCES STORED IN FREE ZONES UNDER THE SCOPE OF KKDİK?

13-06-2025

The KKDİK (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation, which sets out the regulations regarding the production, import, and use of chemicals in Turkey, exclud
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7

CHEMICAL SAFETY ASSESSMENT (CSA)

30-05-2025

The purpose of the KKDİK Regulation is to protect humans, other living beings and the environment from chemicals, to encourage alternative methods for assessing the hazards of subs
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8

CHEMICAL SAFETY REPORT (CSR)

30-05-2025

The Chemical Safety Report (CSR) is a document that compiles and presents the information required for the safe use of a chemical substance. In other words, the CSR is a report tha
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9

CAN THERE BE MULTIPLE REGISTRANT ROLES IN KKDIK REGISTRATION?

29-05-2025

Example Scenario: Under the KKDİK Regulation, should a company that holds both the importer and Only Representative (OR) roles for the same substance in the same supply chain submit two sep
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10

MONOMER REGISTRATION AND SPECTRAL DATA FOR SUBSTANCES USED IN POLYMER MANUFACTURING UNDER KKDİK

29-05-2025

Under the KKDİK Regulation, the registration of polymers and monomers requires particular attention to the following aspects: ► Spectral Data and Chromatogra
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11

KKDIK REGISTRATION FOR CHEMICALS PRODUCED DOMESTICALLY AND EXPORTED ABROAD

29-05-2025

According to Article 7 of the KKDIK Regulation, there is a registration obligation for substances produced in quantities of 1 ton or more
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12

INTERMEDIATE SUBSTANCE REGISTRATION UNDER THE KKDIK REGULATION

29-05-2025

Intermediate substances are chemical substances that are typically used in the production of final products, processed, or combined with other substances, but are not presented as standalone produc
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13

WHAT IS A POISON CENTRE NOTIFICATION (PCN) AND WHY IS IT IMPORTANT FOR COMPANIES TO COMPLY?

28-05-2025

Poison Centre Notifications (PCN) are prepared to reduce the health risks of people exposed to certain harmful chemicals and to ensure that they receive the right emergency health
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14

ESSENTIAL ELEMENTS ON THE LABEL OF DETERGENT PRODUCTS

16-05-2025

As a basic rule, product labels must comply with the current legislation of the country in which the product is marketed. Therefore, the labels are expected to be up-to-date and accurate in terms o
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15

COMPLIANCE WITH REGULATION AND INSPECTIONS ON DETERGENT PRODUCTS

16-05-2025

The preparation of a label that complies with the legislation on detergent products is of great importance for both consumer safety and the marketability of the product. Labels provide critical inf
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16

WHY IS EXPOSURE SCENARIO IMPORTANT?

16-05-2025

Exposure Scenarios (ESS) are critical to ensuring the safe use of chemical substances. Here are a few points that highlight the importance of exposure scenarios:
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17

DO NOT DELAY IN MAKING YOUR PCN-POISON CENTER NOTIFICATIONS!

16-05-2025

Why is PCN-Poison Center Notification so important? Various chemical products offered to the EU market, even if handled properly, can pose undesirable health risk
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18

KKDİK REGISTRATION RESPONSIBILITY FOR SUBSTANCES PURCHASED FROM THE TURKISH DOMESTIC MARKET

14-05-2025

The Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDİK) Regulation was enacted in Turkey to control the impact of chemical substances on human health and
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19

PREPARATION OF THE REGISTRATION DOSSIER IN THE KKDIK REGISTRATION PROCESS

14-05-2025

Under the KKDİK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), individuals and companies who are required to register chemical substances are a
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20

WHAT IS THE KKDIK ONLY REPRESENTATIVE and WHO CAN APPOINT AN ONLY REPRESENTATIVE?

07-01-2025

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21

REACH COMPLIANT SDS (SAFETY DATA SHEET)

07-01-2025

Regulation (EC) No 1907/2006 (REACH) is a legal EU regulation that provides information on the determination, indication, precautions against the hazards of chemicals and the creat
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22

KKDIK Regulation Only Representative Service

06-01-2025

Only Representative refers to an established or legal entity resident in Turkey who is appointed by a manufacturer, formulator or article producer resident outside of Turkey to ful
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23

KKDIK Regulation Only Representative Service

06-01-2025

Only Representative refers to an established or legal entity resident in Turkey who is appointed by a manufacturer, formulator or article producer resident outside of Turkey to ful
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24

What does the Only Representative Mean?

06-01-2025

Only Representative is a real or legal person resident in Turkey appointed by a real or legal person who manufactures a substance, prepares a mixture or produces an article
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25

What is the Difference Between a Only Representative and a Third Party Representative?

06-01-2025

Only Representative is a real or legal person resident in Turkey appointed by a real or legal entity who manufactures a substance, prepares a mixture or produces an article ou
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26

What are the Obligations of the Only Representative?

06-01-2025

The real or legal entity resident outside Turkey that manufactures the substance, formulates the mixture or produces the article must appoint a sole representative to carry out the necessary regist
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27

2025 BIOCIDAL PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

06-01-2025

A guide to current price tariffs including all fees requested by the Ministry dur
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28

KKDIK OFFICIAL FEES FOR 2025 ARE PUBLISHED!

03-01-2025

The updated KKDIK official fee list for 2025, prepared by the Autho
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29

THE UPDATE OF THE CLP REGULATION PUBLISHED!

03-12-2024

The update to the Chemical Classification, Labelling and Packaging (CLP) Regulation was published on 20 November 2024 under Regulation (EU) 2024/2865. The update i
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30

Is it Acceptable to Submit Copies of Documents Related to the Active Substance?

14-08-2024

Unfortunately, the Authority does not consider copies of documents acceptable. Documents related to the active substance (CoA, report, certificate, etc.) must be obtained from the supplier with a w
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31

Our Active Substance Supplier does not want to share the Annex II-A File Requirements due to Confidentiality Reasons, what should we do?

14-08-2024

The Annex II-A active substance data set contains comprehensive information and data about the active substance. The majority of this information is classified as confidential information.
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32

How should the Documents be Prepared According to the Biocidal Product License Application Checklist?

14-08-2024

The file must be prepared in accordance with the Checklist and submitted to the Authority. All documents must be prepared with wet signatures. Since the Environmental Health Department does not hav
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33

INFORMATION ON THE LEAD REGISTRATION DOSSIER WITHIN THE SCOPE OF KKDIK REGULATION

07-08-2024

What is Lead Registration Dossier?  "Lead Registration Dossier" refers to the dossier including the information of the people who undertake respo
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34

CHEMICAL SAFETY ASSESSMENT AND CHEMICAL SAFETY REPORT

22-07-2024

KKDIK is based on the principle that the industry should ensure the production, import, use or release of substances to the market without harming human health and the environment. C
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35

KKDIK EXPOSURE SCENARIO

22-07-2024

What is an Exposure Scenario? Exposure scenario (ES) can be defined as the measures determined to control and, if possible, minimise the negative effects on the environment
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36

INFORMATION ON THE REGISTRATION PROCESS WITHIN THE SCOPE OF THE KKDIK REGULATION

22-07-2024

What is KKDIK? KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation was enforced by Republic of Türkiye, Ministry of Environment, Urb
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37

INFORMATION ON THE CO-REGISTRATION DOSSIER WITHIN THE SCOPE OF KKDIK REGULATION

22-07-2024

What is a Co-Registration Dossier? A co-registration dossier is a dossier prepared by a group of chemical substance manufacturers or importers in order to register the sa
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38

How Should the Registration Tonnage be Calculated within the Scope of KKDIK Regulation?

11-07-2024

The annual tonnage amount must be calculated for the registration dossier.  According to Article 4 (öö) of the KKDIK Regulation, annual quantity: It r
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39

Labelling of Chemicals and Safety Data Sheet (SDS-SDS-MSDS) Compliance Services

05-06-2024

Companies which are in compliance with country specific regulatory requirements are ahead of the game with regard to competition environment of international business. The most substantial hazard c
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40

REACH (1907/2006 EC) Regulation Compliance Services

05-06-2024

Manufacturers and distributors of different sizes are increasingly facing substantial challenges resulting from globalization and newest international regulatory issues. With regard to companies ha
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41

Use of EU Poison Center Notification (PCN) and UFI Code

04-06-2024

In accordance with Article 45 and Annex VIII of the Regulation (EC) No. 1272/2008 (CLP) and, chemical mixtures that are classified as hazardous to human health * and/or having physicochemical **&nb
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42

Global Regulation Compliance and Representation Services

04-06-2024

As CRAD, we provide many different services to companies exporting to the EU to meet legal requirements such as REACH Only Representative, pre-registration, registration, label, SDS, notification,
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43

Use of EU Poison Center Notification (PCN) and UFI Code

04-06-2024

In accordance with Article 45 and Annex VIII of the Regulation (EC) No. 1272/2008 (CLP) and, chemical mixtures that are classified as hazardous to human health *and/or having physicochemical **haza
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44

Who is Responsible for Notification of SDS to ECBS?

26-04-2024

The safety data sheet of substances or mixtures placed on the market the market, shall be uploaded to the specific IT tool in ECBS which is designed for the safety data sheet and provided on the we
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45

Who should get the UFI Code?

22-04-2024

Importers and/or downstream users of EU area are required to obtain a UFI Code for their hazardous mixtures.
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46

How to get UFI Code?

22-04-2024

A format for the Unique Formula Identifier has been defined and a software application has been developed that allows the creation of UFIs by ECHA's website. To generate a UFI
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47

What is UFI?

22-04-2024

UFI stands for "Unique Formula Identifier" and is a code that must be included on the labels of hazardous mixtures. The Unique Formula Identifier (UFI)
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48

Is it Prohibited to use SVHC Substances?

22-04-2024

Suppliers operating in European Union countries are obliged to provide this SVHC information at all stages of the supply chain if their products contain more than 0.1% (w/w) SVHC substances (high r
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49

What is an SVHC Substance?

22-04-2024

SVHC stands for "Substance of Very High Concern" in English and means high risk substances. According to the REACH regulation, SVHC substances, which can be found in vari
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50

What are PFAs?

22-04-2024

Containing more than 4,700 chemicals, perfluorinated and polyfluorinated alkyl substances (PFAS) are a group of commonly used man-made chemicals that accumulate in the human body and the environmen
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51

Who does the PCN Notifications?

22-04-2024

PCN notifications must be submitted by importers and downstream users placing mixtures classified for human health or physical hazards on the market. Notifications can also be made by a third-party
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52

How to Prepare a PCN Notification (Poison Centre Notification) File?

22-04-2024

A PCN notification (Poison Centre Notification) file can be prepared in 3 ways. Online via ECHA Submission portal Via IUCLID with system-to-system serv
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53

What is a Poison Centre Notification (PCN)?

22-04-2024

According to Article 45 of the CLP Regulation, companies placing dangerous mixtures on the market are obliged to provide information on certain dangerous mixtures to the relevant national authoriti
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54

What are the Implementation dates for the UFI Code?

22-04-2024

The obligation to write a UFI code on the label has been implemented for all product types. For mixtures for consumer use : from 1 January 2021 For mixtures for profess
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55

How to Prepare a PCN File?

22-04-2024

Notification dossiers are available through the ECHA submission portal for many countries. However, for some member states, notification files are sent to the institution they determine.
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56

What will be required for UFI Code and PC Notification (Poison Center Notification)?

22-04-2024

EU resident tax number of the company that will receive the UFI code An internal formulation number Information to which EU countries the product will be delivered
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57

What is a PCN-Poison Centre Notification File?

22-04-2024

With the UFI code on the label, the product composition and hazards will be identified to the relevant poison centre, which will ensure faster emergency response.
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58

Where is the UFI Code Used?

22-04-2024

The first step when creating a UFI code is determine whether it is subject to this obligation. The obligation to obtain a UFI code within the scope of Article 45 of the CLP regula
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59

What is the UFI Code?

22-04-2024

The 16-character code, called the Unique Formula Identifier (UFI code), is a mandatory label element and importers and downstream users will be required to file with specific produ
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60

Is Active Substance Registration done in Turkey?

15-03-2024

No, active substance registration is not made within the scope of TR-BPR. Instead, the Annex II-A active substance file, which is the TR-BPR annex, is submitted to the Authority. This file contains
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61

Treated Articles or Biocidal Products?

15-03-2024

In this regard, an evaluation should be made on a product basis. The product's claims, content and intended use are important. In order for a correct evaluation to be made, you can contact our
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62

In which Laboratory are Biocidal Product Analyzes Performed?

15-03-2024

With the Regulation on Amendments to the Biocidal Products Regulation published in the Official Gazette dated 30/12/2021 and numbered 31705, the definition of authorized laboratory is only valid fo
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63

How long does the Biocidal Product Licensing Process take?

15-03-2024

There is no clear time for this. The data provided by manufacturers/applicants and the scope of this data better determine the process. In addition, since the process progresses in line with the de
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64

What are our services within the scope of the Biocidal Products Regulation?

15-03-2024

•    Regulatory compliance support and consultancy •    Acting as representative/registrant •    Label compliance in accord
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65

What should be done for products falling within the scope of the Biocidal Product Regulation?

15-03-2024

If you offer or want to offer your product to the domestic market with a claim stating that it is a biocidal product, a license application must be made within the scope of TR-BPR. O
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66

What Regulations are Followed in the Biocidal Product Registration Process?

15-03-2024

Biocidal Products Regulation (Official Gazette No. 27449 and Dated 31 December 2009) Regulation on Classification, Labelling and Packaging of the Substances and Mixtures (dated 1
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67

What is Biocidal Product?

15-03-2024

These are active substances and preparations that contain one or more active substances, are offered for sale in ready-to-use form and have a controlling effect on any harmful organism chemically o
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68

Neslihan HORUZ / Accounting

20-02-2024

Neslihan Horuz was born in 1995. After having her education at Dilek Sabancı Anatolian Vocational High School in the Department of Accounting, she graduated from Balıkesir University Faculty of Eco
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69

2024 BIOCIDAL PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

01-02-2024

A guide to current price tariffs including all fees requested by the Ministry dur
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70

KKDIK OFFICIAL FEES FOR 2024 ARE PUBLISHED!

03-01-2024

Please find the details regarding the official fees for KKDİK registration dossier
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71

REVISION OF KKDIK REGULATION REGARDING THE EXTENSION OF REGISTRATION DEADLINES PUBLISHED ON OFFICIAL GAZETTE!

25-12-2023

The long-waited Revision of KKDİK Regulation Regarding the Extension of Registration Deadlines published on Official Gazette on the date 23 December 2023 and No: 32408.
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72

DRAFT ADDENDUM FOR KKDIK IS OPEN FOR CONSULTATION!

14-11-2023

On 13th November 2023 Ministry of Environment, Urbanization and Climate Change ( MoEUCC) had circulated a draft amendment to the KKDİK Regulation for consultation and to obtain proposals & opin
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73

NEW DRAFT ADDENDUM TO KKDIK AS DECLARED AT AN AUTHORITY MEETING HELD WITH INDUSTRY STAKE HOLDER ASSOCIATIONS!

23-10-2023

We wish to inform you that; On October 19, 2023, a meeting with the title of "KKDIK Evaluation Meeting" was held at the Ministry of Environment and Urbanization chaired b
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74

REASONS AND COMMENTS REGARDING THE NEED FOR DEADLINE EXTENSION FOR KKDIK REGISTRATIONS

17-10-2023

Author: Melih Babayigit / CAE- Principal Regulatory Consultant                           The lack of
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75

DECISION ON NON-APPROVAL OF ACTIVE SUBSTANCES HAS BEEN PUBLISHED!

11-09-2023

It has been decided that the relevant substances will not be approved for use as biocidal product active ingredients in the specified product types based on COMMISSION IMPLEMENTING DECISION (EU) 20
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76

ATTENTION BIOCIDAL PRODUCT MANUFACTURERS AND IMPORTERS!

04-08-2023

In the first paragraph of Article 11 of the Biocidal Products Regulation, “…. The Ministry may request the content of the file in a physical and/or electronic carrier environment.&rdqu
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77

UPDATE OF REGULATION ON EU CLP IS PUBLISHED!

12-07-2023

Regulation (EU) 2023/1434 has been published in the EU Official Gazette. In accordance with this regulation; New NOTES have been added to section 1.1.3 of Annex VI with the aim of adapting to techn
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78

NEW DATA SHARING PROVISIONS FOR KKDIK

13-06-2023

Ministry of Environment, Urbanization and Climate Change (MoEUCC) had published a set of provisions and rules to be followed for the Joint Submission & Data sharing principles under the scope o
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79

KKDIK DEADLINE APPROACHING- NEW PROVISIONS HAVE BEEN ANNOUNCED!

07-02-2023

KKDİK Deadline approaching- new provisions have been announced by the Competent Authority to support the stakeholders achieve timely submission:  As the time is moving fast to t
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80

2023 PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

02-02-2023

A guide to current price tariffs including all fees requested by the Ministry during the licensing process of biocidal products has been published. Please you can access the guide vi
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81

Buse KAYA / Translator

30-01-2023

Born in Izmir in 1998, Buse Kaya graduated from Yeditepe University Translation Studies Department in 2022, after completing her high school education at the private Sezin High School. After comple
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82

Gülseren SARİKAYA / Chemical Engineer - Chemical Regulatory Specialist / Chemical Assessment Expert

30-01-2023

Gülseren SARIKAYA was born in Istanbul-Kadıköy in 1994, she completed her high school education at Istanbul Anatolian High School. Then, she graduated from Ankara University, Department o
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83

KKDIK OFFICIAL FEES FOR 2023 ARE PUBLISHED!

02-01-2023

Please find the details regarding the official fees for KKDİK registration dossier
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84

11 October 2022 LR & OR Event by MoEUCC Regarding Data Sharing and Progress of KKDIK

13-10-2022

An event organised by Turkey’s Ministry
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85

Esra BAL / Biologist - Chemical Regulatory Specialist / Chemical Assessment Expert

20-07-2022

Esra BAL, was born in Singapore in1996, graduated from Marmara University Department of Biology in 2019. She completed her internship in Istanbul University Capa Medical Faculty Clinical Bioch
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86

Selenay AVCI/ Chemical Engineer - Chemical Regulatory Specialist / Chemical Assessment Expert

18-07-2022

Selenay AVCI was born in İstanbul in 1994. After having her education at Antalya Anatolian High School, she graduated from Department of Chemical Engineering at Izmir Institute of Technology in 201
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87

OFFICIAL LETTER ON LICENSING BUSINESS AND TRANSACTIONS AND USE OF AUXILIARY ACTIVE SUBSTANCES HAS BEEN PUBLISHED!

22-03-2022

The Environmental Health Department has issued the Official Letter dated 10/03/2022 and numbered E-19020089-819-1014, in which it specifies the details of the Biocidal Product licensing work and pr
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88

2022 PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

07-03-2022

A guide to current price tariffs including all fees requested by the Ministry during the licensing process of biocidal products has been published.
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89

IN-SITU GENERATION SYSTEMS INSTRUCTION HAS BEEN PUBLISHED!

02-02-2022

The Turkish Competent Authority has prepared and published the “In
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90

THE REGULATION ON THE AMENDMENT OF THE BIOCIDAL PRODUCTS REGULATION HAS BEEN COME INTO FORCED!

30-12-2021

The Ministry of Health of the Turkish Republic has published the r
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91

USAGE OF UTS BIOCIDAL MODULE AND EXTENSION OF LICENSE VALIDITY FOR BIOCIDAL PRODUCTS IN DIRECT CONTACT WITH THE HUMAN BODY (PRODUCT TYPE-1 AND PRODUCT TYPE-19)

01-12-2021

With the announcement published by Turkish Medicines and Medical Devices Agency (TİTCK), It has been stated that as of 09.12.2021, registration applications for product type-1 and product type-19 b
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92

ACTIVE SUBSTANCE REGISTRATION SCIENTIFIC COMMITTEE FIRST MEETING HELD

01-12-2021

The Scientific Committee on Active Substance Registration, appointed by the General Directorate of Public Health (HSGM) with the official letter dated 24.11.2021 and numbered E-19020089-020-4826, h
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93

ABOUT CESSATION OF USE OF CERTAIN ACTIVE SUBSTANCES

19-10-2021

The European Commission Implementation Decree dated 02/08/2021 and numbered 2021/1283/EU, published in the Official Journal of the European Union dated 03/08/2021 and numbered L279, entered into fo
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94

THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORIZED LABORATORIES HAVE BEEN UPDATED!

24-09-2021

The Instructions on Biocidal Product Analysis and Authorized Laboratories which were published by the General Directorate of Public Health dated 16/08/2021 and numbered E-19020089-020-3305 have bee
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95

THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORIZED LABORATORIES HAVE BEEN UPDATED!

17-08-2021

The Instructions on Biocidal Product Analysis and Authorized Laboratories which were published by the General Directorate of Public Health dated 29/01/2021 and numbered E-19020089-105.99-99-4 have
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96

THE DRAFT REGULATION ON THE AMENDMENT OF THE BIOCIDAL PRODUCTS REGULATION HAS BEEN ANNOUNCED!

17-08-2021

The Ministry of Health of the Turkish Republic has announced the draft regulation on the Amending of the Biocidal Products Regulation aiming to bring the current Biocidal Products Regulation and it
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97

THE USE OF ESBIOTHRIN AS AN ACTIVE SUBSTANCE IN BIOCIDAL PRODUCTS HAS BEEN SUSPENDED.

16-08-2021

The Commission Implementing Decision (EU) 2021/98 published in the Official Journal of the European Union dated 29/01/2021 and numbered L31, not approving esbiothrin as an existing active substance
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98

2022 KKDIK REGISTRATION OFFICIAL FEES ARE PUBLISHED!

04-01-2022

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99

BIOCIDAL PRODUCT LICENSE VALIDITY PERIODS HAVE BEEN UPDATED!

02-06-2021

As known, the license validity periods of all biocidal product licenses issued following the provisions of the Biocidal Product Regulation dated 31 December 2009 and 27449 (4th bis.) will expire on
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100

LABORATORY INSTRUCTION ON PT-1 AND PT-19 BIOCIDAL PRODUCT ANALYSES HAS BEEN PUBLISHED!

10-03-2021

Product Type-1 and Product Type-19 biocidal products whose duties and responsibilities were transferred to the Turkish Medicines and Medical Devices Agency (TİTCK) has published the laboratory inst
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