In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]
Regulatory workshop at PRO BEAUTY EXPO 2024
We invite you to the event, which will be useful for anyone interested in legalization and entering the Ukrainian and EU markets with cosmetic and medical products. At the seminar, you will receive comprehensive information on legal regulation and legalization procedures, as well as familiarize yourself with the specifics of entering the EU market.
The seminar will take place on March 13, 2024, in Hall No. 4 as part of the Pro Beauty Expo exhibition from 11:00 to 16:00.
Cratia’s experts will provide up-to-date information, share practical experience, and aspects of product certification in the beauty industry.
The seminar is open to all who will be participants or visitors of the exhibition. If you need a ticket for the seminar, you can contact us or purchase a ticket to the exhibition at the following link: https://beautyexpo.com.ua/program/rehuliatornyi-workshop.
Our company is also an exhibitor at the event, and you can visit our booth No. 1A-2-1, where our experts will be happy to assist you with any questions.
Detailed event program:
Seminar
“Regulatory workshop on cosmetic products, medical devices, and medicines for aesthetic medicine and cosmetology”
March 13, 2024 | 11:00-16:00 | IEC, Hall No. 4, Pav.1, Entrance 1C
Block 1: Cosmetic Products (cosmetics, perfumes, skincare, hair care, nail care, oral care, etc.)
Speaker: Oksana Oliynichuk, Head of FMCG Department at Cratia
11:00 – 12:00 (60 mins):
- Legalization of cosmetic products during the transitional period;
- New requirements for cosmetic products;
- GMP certification;
- Assessment of compliance with the Technical Regulation on cosmetic products;
- Requirements for composition and labeling;
- Preparation of product information file;
- Safety report;
Notification in the Ministry of Health portal.
Speaker: Maksym Bagrieiev, CEO Cratia
12:00 – 13:00 (60 mins):
- Market entry into the EU (27 countries) with cosmetic products;
- Placement of cosmetics under own TM;
- PIF development for the EU;
- Labeling requirements in EU countries;
- Notification in CPNP;
- Responsibility and penalties in different countries;
- Practical tips for legalizing cosmetic products in the EU.
13:00 – 13:30 (30 mins): Q&A session.
Block 2: Medical Products (fillers, botox, lasers, breast implants, meso threads for 3D lifting, chemical peels, cannulas, needles, etc.)
Speaker: Viktoriia Moroz, Key Account Manager at Cratia
13:30 – 15:00 (90 mins):
- Conformity assessment of medical devices for aesthetic medicine;
- Classification of medical devices, medical purpose, and intended use;
- Types of conformity assessment procedures for aesthetic medical devices;
- Requirements for technical documentation;
- Authorized representative of the manufacturer in Ukraine: role and functions;
- Placement of medical devices under own TM;
- Maintain certificates and annual surveillance;
- Implementation of changes;
- Market surveillance and responsibility.
Speaker: Maksym Bagrieiev, CEO Cratia
15:00 – 15:30 (30 mins):
- Basics of medicines registration;
- Types of registration procedures;
- General requirements and requirements for registration dossier;
- Pharmacovigilance.
15:30 – 16:00 (30 mins): Q&A session. Professional discussion with all speakers. Conclusion of the seminar.
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