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Parliamentary questions
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11 December 2018
E-006211-18
Question for written answer E-006211-18
to the Commission
Rule 130
Rory Palmer (S&D)

 Subject:  Vitamin B12
 Answer in writing 

Under current legislation in the UK, persons diagnosed with pernicious anaemia can receive Cyanocobalamin, known also as Intra Muscular B12 (IM B12) injections, once every three months. Many sufferers explain that this dosage is not sufficient for tackling the symptoms of this illness, and they have been forced to self-medicate themselves by ordering medication from abroad.

The Medicines and Healthcare products Regulatory Agency (MHRA) states that while the licensing and classification of Vitamin B12 injection in the UK dates back to the 1960s, the introduction of EU Directive 2001/83/EC in 2001 reaffirmed that it should be classified as ‘prescription only’. IM B12 is considered as prescription only by the MHRA because it is ‘normally prescribed by a doctor for administration by injection’, a clause included in EU-UK legislation to classify medication as prescription only.

Can the Commission outline the steps required to reclassify IM B12 as an over-the-counter (OTC) medication within the boundaries of European Directive 2001/83/EC?

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