MSD received administrative disposition for packaging

60 tablet packaging 'exception recognition' review order considering the characteristics of Isentress

The drug will be suspended from the 15th

There will be no problem with supply and demand

MSD Korea has been subject to administrative disposition for violating the provisions of supplying small packages.

 

However, it was confirmed that they were looking for a way through the exception.

 

Considering the characteristics of taking 2 tablets a day, it applied for relief saying that it had to admit an exception to the packaging of 60 tablets.

 

However, there are many opinions that time is imminent as the import suspension measures for the item will proceed from next week immediately.

 

#The MFDS imposed administrative measures to suspend manufacturing and import operations for pharmaceutical companies that violate the regulations on supplying small quantities of medicines in small quantities.

 

MSD Korea was found to violate Article 42 of the Pharmaceutical Affairs Law due to the lack of standards for supplying small quantities of medicines in 2019, two items, Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized).

 

According to the supply regulations related to package packaging for pharmaceuticals, manufacturers must supply 10% of the annual manufacturing/import volume for each item.

 

However, if there is little data or product demand on inventory and disposal, the ratio can be set lower than 10%.

 

In the case of MSD, it violated the regulation of 30 tablets packaging.

 

Accordingly, the drug cannot be imported into Korea from January 15 to February 14.

 

In the case of a violation of the current regulations on supplying small-sized packaging units, an administrative disposition for one month of suspension of the manufacturing business is applied, and in the case of the second violation, a three-month suspension of manufacturing business is imposed.

 

However, MSD is planning to receive an exception to the regulation of the small package as both Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized) have characteristics of dosage.

 

The dosage of Isentress published on the MSD official website is 400mg twice a day in combination with other antiretroviral drugs for the treatment of adult patients infected with HIV-1 on an adult basis.

 

According to the current regulations, the two products must be packaged in a small package of 30 tablets or less, but the related product is characterized by taking 2 tablets a day, so it will be recognized that there is only one packaging unit of 60 tablets.

 

MSD noted that it is in the process of being reviewed with relevant data submitted to the MFDS in order to obtain an exception.

 

An MSD official said, "We have submitted data to receive exceptions considering the dosage of the product.

 

The package of 60 tablets should be accepted as an exception considering the dosage characteristics of the drug." However, the time is imminent in that the administrative disposition procedure will start from the 15th, apart from the review of the MFDS.

 

An MSD official said, "As a result of the current analysis, the problem in supply and demand of medicines due to import suspension is expected to be negligible."