Health ministry will check out drug labelling claims

From: Cyprus Mail Cyprus Mail By Evie Andreou

If media reports that 40 per cent of the medicines intended to stock government hospitals have unsuitable labelling, the health ministry will take corrective action, it said in an announcement.

The statement came in response to allegations made in Politis newspaper that 271 out the 676 imported medicines intended to stock the government hospitals were found to have insufficient labelling. The irregularity concerns medicines imported to Cyprus through mutual recognition agreements (MRA) with other countries.

The health ministry said in a brief announcement that it was not officially informed of the issue by the state pharmaceutical services and was awaiting their report.

“If gaps are found in the procedures, it [the ministry] does not rule out corrective measures, including full revision of the surveillance system of the medicines market,” the ministry said.

Inspections on all imported medicine were carried out by the pharmaceutical services after a number of drugs, already in the shelves of state pharmacies contained instruction sheets in German, but not in Greek, as required by law.

The ministry had said that the issue was to be dealt with by the medicines council which would review the case and take, if necessary, measures against the importer. It also said that the medicines did not pose any health risk, and advised patients to continue to take their medicine as per their doctor’s instructions.

Politis reported that during the check, among the companies that intended to supply medicines with insufficient labelling were members of both the Cyprus Pharmaceutical Association (CPA) and the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA).

“Let anyone who breaks the law, face the consequences,” said the head of the CPA, Avgoustinos Potamitis. He said that it was not only the company that should face consequences but the pharmaceutical services, which had allowed the irregularity.

He added that the majority of the medicines intended for the Cypriot market, are required by law to include instructions in Greek, and that there were only by a few exceptions, and after permission, that some medicines come only with English instructions, but “there is no provision in the law for instructions only in German”.

Potamitis also said that local import companies, to reduce costs, order joint packaging with Greek companies but if that is not possible, they have to have packaging printed for the Cypriot market especially.

The head of the KEFEA, Kyriacos Mikellis, said in an announcement that the reports took them by surprise and that they had requested the pharmaceutical services contact the companies in question and investigate the data reported by the newspaper.

Mikellis said that this issue should not be a concern for patients, and called on the ministry to investigate the allegations and take the necessary measures.

“KEFEA in no way wishes to see the violation of the relevant legislation for labelling as it has always been a priority for its members who have invested significant amounts  of money and time in compliance to serve Cypriot patients,” the announcement said.

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