Archive
International News Services archives articles supplied to clients one year or more after initial publication. These articles are protected by a password and not made available to readers without permission from clients. They are used as a background resource by agency journalists. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.
MEDICAL EXPENSES
BY KEITH NUTHALL
THE EUROPEAN Court of Justice (ECJ) has ruled that a law governing the reimbursement of medical expenses paid by German civil servants breaks European Union (EU) fair trade treaty commitments because it insists that the prospect of success for such treatment must be higher when bought abroad than in Germany.…
EMEA: THREE LINKS
BY KEITH NUTHALL
GUIDELINES on requirements for vaccine antigen master file certification have been released by EMEA, (http://www.emea.eu.int/pdfs/human/bwp/454803en.pdf), as well as guidelines on the scientific data requirements for a vaccine antigen master file (http://www.emea.eu.int/pdfs/human/bwp/373403en.pdf). Meanwhile, the agency has released guidelines on recording core data for herbal medicinal substances and preparations (http://www.emea.eu.int/pdfs/human/hmpwp/004101en.pdf).…
PARALLEL DISTRIBUTION
BY KEITH NUTHALL
GUIDANCE on the parallel distribution of authorised medicinal products in the European Union (EU) is being drawn up by the European Agency for the Evaluation of Medicinal Products (EMEA), with a final version due to be released by the end of April.…
EMEA: PACKAGING & HOT COUNTRIES
BY KEITH NUTHALL
THE EUROPEAN Agency for the Evaluation of Medicinal Products (EMEA) has released updated guidelines on the use of plastic primary packaging materials in the pharmaceutical industry, (http://www.emea.eu.int/pdfs/human/qwp/435903en.pdf). It has also on stability testing for medicines manufactured in hot countries outside the European Union (EU), classified by Brussels as climatic zones III and IV, (http://www.emea.eu.int/pdfs/human/qwp/614203en.pdf).…
COUNCIL MEDICINE REFORMS
BY KEITH NUTHALL
THE EUROPEAN Union (EU) Council of Ministers has approved a string of reforms to EU pharmaceutical legislation, designed to boost research, innovation and the working of the EU internal market while protecting patients. They include a new regulation on authorising and supervising medicines (and on EMEA); directives on EU codes on human and veterinary medicines and a directive on traditional herbal medicines.…
CHILD MEDICINES
BY KEITH NUTHALL
WIDE expert consultation is being carried out by the European Union (EU) on the effect of adult medicines on children, reflecting widespread concern that such drugs need specially assessed for young patients. Notably comments are being requested by the European Agency for the Evaluation of Medicinal Products (EMEA) on the effect of medicines on young kidneys, for instance.…
EU - PRECURSORS
BY KEITH NUTHALL
REFORMS to European Union (EU) drug precursor legislation have been approved by the European Parliament and the EU Council of Ministers. They strengthen controls on two key substances – potassium permanganate and acetic anhydride – used to produce cocaine and heroin.…
US TRUST LAWS
BY KEITH NUTHALL
EUROPEAN pharmaceutical companies Hoffmann-La Roche, BASF and Rhône-Poulenc are being supported by the International Chamber of Commerce in a US Supreme Court case that could make United States courts de facto global anti-trust regulators, even in cases with a negligible USA impact.…
AVIATION SMOKING CASE
BY PHILIP FINE
GREECE’S Olympic Airways has been ordered to pay US$1.4 million by an American court after a man died in 1998 from an asthmatic reaction to on-board cigarette smoke. The judges ruled airline attendants had negligently failed to heed his request to move to a smoke-free zone.…
MACEDONIA REFORM
Keith Nuthall
THE EUROPEAN Union (EU) organisation tasked with reviving the war-damaged south-eastern Balkans has released a plan to move Macedonia’s wine industry from a bulk producer of cheap wine towards a higher-end sector, tapping western export markets. The country has a wine-making tradition, still exhibits a (former) communist command economy inspired indifference to quality.…