source from FDA Thailand(Cosmetic (moph.go.th))
Pre-Marketing Control
Technical Requirements of Cosmetics
The technical requirements cover the positive and negative listings of ingredients, labeling and claims, pre-marketing requirements, and Good Manufacturing Practices (GMP). These technical requirements serve as the guidelines for quality and safety control.
Under the current cosmetic regulation, cosmetics will require the notification of the products to FDA prior to being manufactured or imported in Thailand. .
Pre-Marketing Requirements
Manufacturers or importers of cosmetic products must notify the information of cosmetic products to the authority prior to producing or importing at the customs. The steps for notification are as follows.
1. Notify the information of cosmetic products to the authority prior to producing or importing. Once the information is completed and correct, the applicant will received the notification receipt which is valid for 3 years.
2. Manufacture or import the cosmetic product according to the notification.
3. Prepare label. Information must be written in Thai language and must be the size that is easily legible. The contents must be the accurate and must not be misleading. References should be documented for inspection.
4. Advertise the cosmetic product based on its fact without misleading contents. References should be documented for inspection.
Details for notification include
1. Applicants are manufacturer (repackaging included), original equipment manufacturer, and importer.
2. Information for notification includes
2.1 Information of the applicant such as name and address of manufacturer or importer or storage site
2.2 Information of the cosmetic product such as name, Brand name ( Trade name) , catagories and ingredients.
2.3 Submitting an notifying form (Jor Kor)
2.4 If the manufacturing or storage sites are located in Bangkok, the manufacturers or the importers must notify at the Food and Drug Administration office. If the manufacturing or storage sites are located in other provinces, the manufacturers or the importers must notify at the provincial public health office where the sites are located. The manufacturers or the importers may also notify the information via the computer network of the Food and Drug Administration.
Post-Marketing control
Five areas of post-marketing activities, namely inspection, market surveillance, advertisement investigation, adverse product reaction surveillance, and improvement of manufacture, are intensified.
Inspection
Inspections will be performed periodically throughout the year. The activities, including inspection and product sampling, will be carried out in accordance with the annual plan and in response to the complaints or reports of adverse reactions or surveillance. The collected products will be tested for fraudulent characteristics. Any products found to be harmful to human health will be recalled or confiscated under the authority of FDA, and will eventually be destroyed in order to ensure that such products will not be re-marketed.
Surveillance and Advertisement Investigation
Market surveillance is performed all year round and includes the investigation of product labeling and the collection of marketed product samples at the inspected place. All claims imprinted on the labels of cosmetic products must have the supporting evidence kept in a ready-to-be-delivered manner.
Advertisements of cosmetics must indicate the products' benefits pertaining to cosmetic scope and purposes. Cosmetic claims are forbidden from indicating that the products have any pharmaceutical characteristics or capability to affect or alter human body's functions or structure; otherwise such products will be regarded as drugs and thus manipulated under the Drug Act instead. Additionally, all advertisements must neither claim nor indicate that those cosmetic products have the capability which, in fact, does not exist or is the cause of misunderstanding in their quality.
The cosmetic products with fraudulent claims in labeling or advertising will be recalled and followed by inspections.
Improvement of Manufacture
The manufacturer's practices play a major role in manufacturing cosmetic products. Without appropriate guidelines for manufacturing practices, the manufacturers will hardly be able to improve the manufacturing process.
Hence, the objective of this activity is firstly to provide basic steps for cosmetics manufacturers to develop their good practices and improve the standards of domestic manufacture.
The production of good-quality cosmetics requires close supervision, thorough monitoring and strengthened inspection in every step of the manufacturing processes. As such, the manufacturing practices of cosmetic manufacturers will be assessed alongside the product sampling. The Certification of Good Manufacturing Practices will be awarded to the qualified manufacturers.
The Good Manufacturing Practices guidelines are designated to help the manufacturers to improve or develop their practices in manufacturing cosmetic products. The guidelines cover various topics, namely definitions, personnel, premises, sanitation, equipment, raw materials and packaging materials, production procedures, quality control, documentation, product recall, internal audit, recording of product distribution, complaints and report of adverse product reaction, and product return.
The manufacturers and the Thai Food and Drug Administration (FDA) use these guidelines for their operations and inspection to ensure the standard of products manufactured.
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