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Published online by Cambridge University Press: 20 January 2017
The external presentation of medicinal products is fundamental in ensuring their safe use from a regulatory perspective. Indeed, the primary purpose of labeling and packaging of medicine is the clear identification of the conditions for safe use.
1 See the best practice guidance on labelling and packaging of medicines, Medicines and Healthcare products Regulatory Agency (MHRA) Guidance Note No. 25 (June 2003).
2 As far as the EU scenario is concerned, see the interesting Case T-123/00 Thomae v. Commission.
3 Detailed information about this conference can be obtained from the website of United States Pharmacopeia (USP), available at <http://www.usp.org/meetings/workshops/nomenclatureWorkshop.html> (last accessed on 29 October 2010).
4 The information which should be included in SPCs is indicated in Article 11 of Directive 2001/83/EC.
5 A Guideline on Summary of Product Characteristics, part of Volume 2C, Notice to Applicants, available on the Internet at <http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm> (last accessed on 24 October 2010).
6 The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (e.g., vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product into the market; the EU legal framework is specified in Directive 2001/83/EC relating to medicinal products for human use, as amended by Directive 2004/27/EC – Article 114. Further information is available on the Internet at <http://www.edqm.eu/en/Human-Biologicals-OCABR-611.html> (last accessed on 26 October 2010).
7 As example, the name of the disease and specific characteristics of the microorganism (e.g. live, inactivated, absorbed) is specified in a vaccines name, e.g., Tetanus Vaccines (absorbed).
8 International Non-proprietary Names (INN) for Biological and Biotechnological Substances, available on the Internet at <http://www.who.int/medicines/services/inn/BioRevforweb.pdf> (last accessed on 26 October 2010).
9 The requirements for labelling information are indicated in Title 21 Code of Federal Regulations, part 201, available on the Internet at <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.66> (last accessed on 29 October 2010).
10 SPL-related information is available on the Internet at <http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm> (last accessed on 26 October 2010).
11 Title 21 CFR, Part 207, available on the Internet at <http://www.access.gpo.gov/nara/cfr/waisidx_06/21cfr201_06.html> (last accessed on 26 October 2010).
12 The acronym “USP” stands for United States Pharmacopeial (USP).
13 Available on the Internet at <http://goldbook.iupac.org/index.html> (last accessed on 24 October 2010).
14 Novartis Pharmaceuticals Corporation v. O. Leavitt, United States Court of Appeals, District of Columbia, Circuit 435 F3d 344. See in particular paras. 33–34 of the decision.
15 In the context of this procedure the stimuli article “Toward a Uniform System for Naming Vaccines and Polyclonal Immune Globulins”, published on Pharmacopeial Forum, Vol. 33(5) [Sept.–Oct. 2007] which is available on the Internet at <http://www.usp.org/pdf/EN/USPNF/Vol33No5Stimuli.pdf> (last accessed on 29 October 2010) is interesting.
16 Title 21 Code of Federal Regulations, part 600 (Biological Products: general), subpart a (general provision), 600.3 (definition), sub clause (k), available on the Internet at <http://cfr.vlex.com/vid/600-3-definitions-19714695> (last accessed on 26 October 2010).
17 The proper name represents the same concept as the “generic name” does for a chemical medicine but it applies only to biological medicinal product.
18 See Pharmaceutical Administration and Regulations in Japan, available on the Internet at <http://www.nihs.go.jp/mhlw/yakuji/yakujie0808.pdf> (last accessed on 26 October 2010).