Distribution and sale of apparently unlicensed pharmaceuticals in Malta

GRTU Pharmacy section representative Mario Debono has on behalf of GRTU today written to The Medicines Authority on the issue in caption. Below is the letter that was sent.

It has been repeatedly brought  to the attention of GRTU that there is a large number of pharmaceuticals in Malta that do not have the necessary MA number that certifies that the products are licensed for sale in Malta. Indeed, this situation has been going on for quite some time, despite the fact that more than a year has passed since the Health Ministry deadline for all products distributed and sold in pharmacies to be numbered according to their MA registration.

We are concerned that whilst two of our member companies have been taken to the courts and asked to pay exorbitant fines for non compliance to the Medicines Act, some other companies have been flouting the law and acting with impunity by ignoring the law and not numbering their products according to their licence.

This is grossly unfair in respect to those companies that have invested in order to become legally compliant, and represents an element of unfair competition.

Technically, any pharmacy purchasing and dispensing  products that should have an MA number, but hasn't,  is breaking the law, and we cannot  run the risk of prosecutions against pharmacy owners because of this. Some pharmacies are also distributing medicines from the POYC system that in the majority do not have the required MA number. We expect the GHPS to lead by example and ensure that any medicines that should carry the MA number do so.

Our position regarding products that carry a licence according the Art.126A of the EU regulations is the same. We contend that there is no reason why these products should not also carry their 126A number. This is important due to any Pharmacovigilance issues that may arise, besides the fact that there is also an element of unfair competition against those who are compliant because they print the Maltese MA number on the packs.

As you know, the affixing of MA numbers is done under GMP, as it should, and at a not inconsiderable cost. There should be a level playing field as regards costs for all, be they MA holders, PLPI holders or 126A Licence holders.

There is also the language question. The MA must ensure that all pharmaceuticals dispensed have a PIL in the English language. There are quite a few products that don't. This is unfair to patients and proscribes, as well as pharmacists, who cannot or do not know that there is access to the English SPC and PIL  from the Authority's website.

We must therefore ask you to immediately enforce the current regulations and if this is not possible, to immediately recall all products not complaint with the law until they are.

As you know, we have verbally expressed our concerns numerous times, but whilst understanding that the resources of the Medicines Inspectorate are finite, the current situation has to be rectified.

Should you have any difficulty in identifying non compliant products, GRTU has compiled a list of products that do not comply with the current licencing regulations.

We are copying this letter to the appropriate Competition Authorities for any interest they may have in the matter