ÜTS cosmetic notification: what Türkiye asks for before the sale.

ÜTS is the Product Tracking System of TİTCK, the Turkish Medicines and Medical Devices Agency, and its national electronic database for cosmetic notifications. The Responsible Person notifies, before the product is placed on the market.

The Cosmetics Law is as short: notification is compulsory before the first sale, and a notification missing information or documents counts as not made. This is notification, not approval: the system records the product and its file, and the Responsible Person answers for it.

It is a separate role from the Responsible Person, with its own article. The regulation says what the person is responsible for and who qualifies; it says nothing more about the job.

1. The role

   The Responsible Person employs a sorumlu teknik eleman, the person who checks that the product meets the cosmetics rules and good manufacturing practice before it is placed on the market.

2. Who can fill it

   The regulation names chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists.

3. Doing it yourself

   A Responsible Person who has one of those qualifications may take the role personally.

4. In ÜTS

   The company adds the sorumlu teknik eleman to ÜTS and signs the application; the person then confirms it from their own login, and only then is the registration complete.

Articles 7(1), 7(3) and 7(4) are the source; the ÜTS steps are from TİTCK’s guide, Article 8. When we are your Responsible Person in Türkiye, a chemist on our own staff holds this role (Expert services); the platform on its own does not.

Article 16(1) lists them, and Article 16(2) adds the label. TİTCK’s guide shows the same data entered in three steps.

The guide also asks for a GS1 barcode, different for each product, a safety assessment report among the declaration types, and the address of the product information file. The fee and the review time are not in the regulation or the guide, so this page gives none.

The notification is the last step, not the first. Five things have to be in place before the application is signed.

1. 01The company is registered

   Registration comes first, in ÜTS and in TİTCK’s application system (EBS), both at the same time. The guide says to sign in with e-signature, e-Devlet password or mobile signature, take the company data from MERSİS or VEDOP, and attach the trade registry gazette.

2. 02The technical person is added

   Step two of the registration: see the section above.

3. 03The safety report is written

   Article 13(1) requires a safety assessment, with a cosmetic product safety report (ÜGDR), before the product is on the market. The report is one of the product information file’s contents.

4. 04The product information file is ready

   Kept by the Responsible Person for ten years after the last batch, at the address on the label, in Turkish or English. Article 14(4). How to keep a PIF.

5. 05The label is final

   Article 16(2) asks for the label as an image, so ÜTS needs the artwork as printed, not a draft.

The platform prepares what the notification rests on; it does not submit to ÜTS. The Responsible Person service in Türkiye, which we quote per scope, includes the ÜTS notification in our name.

Notifying does not close the file. Changes go through ÜTS, and the file behind it stays current.

• The application shows a status: awaiting review, under review, reviewed, awaiting signature, rejected or withdrawn, as the guide lists them. A reviewed application has its decision in the application detail.
• Article 16(4): when anything notified changes, the Responsible Person updates it without delay.
• A formula change on an update needs a written reason; the first notification leaves it empty.
• The product stays on the file side too: keep the PIF and the report current as new information comes in. Regulatory Watch names the products a changed annex touches.