The procedure for compliance of medical devices with the requirements of technical regulations entered into force on July 1, 2015, and since then only about 5% of companies that are fully confident in the quality and safety of the products supplied have passed the re-registration procedure. These include Allergan, which received its Integrated Quality Management System certification in early September 2016.
In this regard, Aleksey Filchukov – Head of the group of managers for medical public relations of the company "Allergan Ukraine" – emphasized the role of compliance with the rules for the sale of medical devices (Class III) in ensuring safety when using this category of products.
How Allergan fights counterfeit products
Rev. The last few years there has been an unprecedented increase in counterfeit products. How does Allergan deal with counterfeit products?
A.F. The first indicator of counterfeit products – low price. As a rule, a company sets a uniform pricing policy for its entire distribution network. The price of the original product cannot be lower than the official price. An exception may be special promotions, which are openly announced by the company.
There are two reasons for such promotions: they can be timed to coincide with some significant events and have an expiration date, or they can be due to the need to quickly sell products from the warehouse due to the approaching expiration of the storage period, which the company communicates honestly and openly.
If information is received about the appearance of a low-quality product, the distributor company is obliged to immediately inform the Ministry of Health about this fact, which in turn publishes an official letter with the number and series of the low-quality batch and a detailed description of the signs of falsification. Such a batch must be withdrawn from sale for further disposal.
Rev. How does your company protect a doctor from unscrupulous suppliers?
A.F. It is important to understand that a doctor cannot always visually assess the quality of products received from a distributor for quality. However, there are additional tools to protect against counterfeiting. Any batch of drugs must be accompanied by a registration certificate and a package of documents confirming their purchase (fiscal receipt, etc.). It is also important to note that a genuine product can always be purchased through a non-cash form of payment, in case of refusal, there is a high probability that you are dealing with a fake.
Red. Why should I buy and use only products that have certificates of conformity or a registration certificate in Ukraine?
A.F. Different countries around the world have their own requirements for medical devices to obtain permission for use in medical practice. In Ukraine today is a transitional period. Taking care of their reputation and the safety of the end user, official distributors of products (this applies not only to Allergan) go through the registration procedure and receive a quality / conformity certificate of the country where they plan to do business.
Today, the list of standards that Allergan fillers comply with is presented in the table:
|
Quality standards |
Country |
|
- ISO 9001, ENISO 13485, ISO 13485 |
International quality standards, EU countries |
|
- Canada’s Medical Devices Regulations |
Canada |
|
- 21CFR 820 : FDA Quality System Regulation (Medical Device) |
USA |
|
- 21 CFR Part 4 : Regulation of Combination Products |
USA |
|
- TG(MD)R: Regulations for medical devices in Australia. |
Australia |
|
- Resolution of RDC N°16: Technical Regulation for Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices and gives other provisions |
Brazil |
|
- Ordinance n° 169, 2004 (QMS Ordinance - Japan): Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents |
Japan |
|
- Ordinance n° 136 (GQP Ordinance - Japan) (current edition in application): Standards for quality assurance for drugs, quasi-drugs, cosmetics and Medical Devices. |
Japan |
|
- Technical Regulations of medical devices approved by the Decree of the Cabinet of Ministers of Ukraine from October 02, 2013 No. 753 |
Ukraine |
As you can see from the table, our products are presented in such markets as the USA, Canada, Australia, Brazil, Japan, European Union countries, where the requirements and quality standards are the most stringent for products allowed for medical practice. And it is very pleasant that Ukraine was added to this list in 2016.
Since the doctor himself chooses and uses hyaluronic acid fillers, he is the final link responsible for the result of the injection or application of a particular product. In the event of a design defect / development of an undesirable reaction to a drug purchased from an official distributor and having a registration certificate, the responsibility for the sold drug is also borne by the manufacturer and distributor (a complaint is filed, sent to the manufacturer and to the Ministry of Health).
However, if a low-quality product was purchased on the black market, the doctor has no protection, in case of any problem, he remains alone with her, risking the patient's health and his reputation.
A genuine product can always be purchased through a non-cash form of payment, otherwise there is a high probability that you are dealing with a counterfeit.
In early September 2016, the Allergan plant (Pringy, France), which manufactures medical products based on Juvederm® hyaluronic acid, passed an audit for compliance with the Ukrainian Technical Regulations for Medical Devices.
During this audit, it was found that the Allergan (Pringy) plant has its own Quality Management System, which has been certified by the notified body LNE/G-MED to meet the requirements of ISO 13485 and Directive 93 /42/EEC. The company also undergoes regular inspections by the FDA.
During the audit, the commission received objective data that confirm compliance with the comprehensive Quality Management System Allergan for the products «Implants for soft tissues Juvederm®» requirements of the Technical Regulations.
It has also been determined that product quality is monitored at all stages of production, nonconforming products are immediately withdrawn, and Allergan takes action on an ongoing basis to prevent the production of nonconforming products.
The Allergan Plant (Pringy, France) received a certificate of conformity to the Integrated Quality Management System valid for five years.
Based on the results of this audit, the authorized body of SE "UMTSS" issued the Allergan plant (Pringy, France) with a certificate of conformity to the integrated Quality Management System, valid for five years.
Estet-portal.com reminds that the presence of the CE symbol on the product labeling, as well as documents confirming compliance with the European Directives on medical devices and the right to find the product on the EU market, does not give the right to be placed on the Ukrainian market without a national procedure.
Therefore, each company selling medical products must have the appropriate state permits and carry out its activities exclusively in the legal field – this will not only avoid undesirable consequences as a result of the sale of low-quality products, but also demonstrate care for the health and safety of patients, as Allergan does.
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