Latest developments Pharmaceutical


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ONGOING: From 9 February 2019, under the Falsified Medicine Directive, all prescription drug makers will be required to adhere to new rules issued by the EU in October 2015 [144]. There are worries companies may not have met this deadline.

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ADOPTED: In May 2017, drugs which contain acetaminophen, most commonly found in paracetamol, must feature warning labels regarding liver damage. ‘Contains acetaminophen’ must also be displayed in bold, red text. Plain language labelling amendments introduced June 2015 for prescription products, and 2017 for non-prescription products. [137][138]

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ADOPTED: In May 2017, drugs which contain acetaminophen, most commonly found in paracetamol, must feature warning labels regarding liver damage. ‘Contains acetaminophen’ must also be displayed in bold, red text. Plain language labelling amendments introduced June 2015 for prescription products, and 2017 for non-prescription products.

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ADOPTED: Mandates that off-patent drugs must carry a label which states it is a generic medicine [141]. Labels must contain legible and indelible characters, “Medicamento Genérico” must be in red capital letters (Pantone Red 032) and both this and the ICD must each be of a size at least 20% larger than that of the name/trademark as applied to the product.

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ONGOING: Limited size of paracetamol packets to 20 tablets in 2013. [142] New labelling rules introduced in 2016 with four year transition period. Changes include: ‘active’ ingredients prominent on front of packaging, warnings and potential allergens dipslayed clearly, space allocated for pharmacists to provide information. [143]

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ADOPTED: A 1998 law limits the size of paracetamol packages to 32 tablets if sold in pharmacies, and 16 tablets if sold from shops [153].

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ADOPTED: A 1998 law limits the size of paracetamol packages to 32 tablets if sold in pharmacies, and 16 tablets if sold from shops [153].