31/05/2019, 10:54 AM

The 1st of July is going to mark the time limit in which health supplement factories, importers must fulfill and be certified as Good Manufacturing Practices for Health Supplement (“GMP – Health Supplement”) is over.

This means that, if during more than one year ago (since the 2nd of February, 2018, the effective date of the Decree No. 15/2018/ND-CP), health supplement manufacturers, importers those have not paid attention to improve its manufacturing conditions in accordance with regulations on GMP - Health Supplement of the Ministry of Health, such as implementing requirements on capital scale, factories, equipment and devices, and personnel, now would be closer and closer to the risks of being forced into stop production and import.

Based on statistic of the Department of Food Safety - Ministry of Health (VFA), up to now, there have been about 3500 health supplement manufacturers across the country. However, those who really make investment to upgrade their manufacturing facilities such as factories, equipment and personnel meeting with the GMP standards are just 0.11%. It means the remaining of 99.89% could be the ones who will risk their operation as legal consequence resulted from such a disqualification.

As the same situation, health supplement importers who cannot present GMP-equivalent documented evidences will also be subject to the cease of imports, regardless whether the imported products are complete declaration of conformity of national standards or not.

The remaining one month looks urgent for such factories/importers with too many things to do to minimize negative impact from enforcement of these regulations.

Factories need to draw a specific plan to improve production facilities and apply for being certified GMP by the competent authority. At the same time, outsourcing to another factories who is qualified GMP – Health Supplement to produce products is also an interim alternative worth to be seriously considered to limit business interruptions.

Importers need to urgently ask manufacturers/exporters to provide GMP-equivalent documented evidences in accordance with regulations.

If you are looking for a support solution, contact ATIM LAW FIRM at email address for further detail