Article 10(a)
Applications submitted under Article 10a are also known as a “well established use” applications and must be supported by substantial published literature. These applications are particularly challenging as a link must be established between the proposed product, and the products used in the published literature studies. It is not uncommon for Regulatory Authorities to request bioequivalence studies in order bridge data. Consequently, applications submitted under this little used legal basis should have a very similar composition pharmaceutical form, strength and route of administration. It is recommended to seek advice prior to submitting applications under Article 10a.
Article 10(b)
Article 10b is the legal basis for combinations of active substances that have not previously been used in combination for therapeutic purposes. The indications are usually expected to be linked.
Article 10(c)
Article 10c is used for the submission of MA applications known as “Simple” applications whereby a MAH may grant another company full access to all pharmaceutical, clinical and non documentation for the purposes of applying for their own MAA for the same product. Also called “copy licenses”, the only details that may be amended as part of the license application are the company and product names. All other information must be identical.
