The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a notification on imminent request for the production and marketing of active pharmaceutical ingredients (API) in the European Economic Area (EEA) which comprises all countries coming under the European Union (EU) including Iceland, Liechtenstein and Norway to adhere to the Directive 2011/62/EU, from July 2, 2013.
The regulatory authority, MHRA is now part of the expert team to ensure formulation of polices for the EU. The EU utilises the MHRA capability to ensure further strengthen regulations and making sure API manufacturers are able to adhere to the directive with no hassles creating a smooth passage of their export consignments, informed an official associated with the development.
According to Directive 2001/83/EC as amended, all active substances used in medicinal products marketed in the EEA must be manufactured in accordance with the EU Good Manufacturing Practice (GMP) or, if imported, with equivalent rules. But the Directive 2011/62/EU, mandates the importation in the EEA of active substances which is possible with three options.
In the first case, the consignment should be accompanied by a 'written confirmation' by the competent authority of the exporting third country that the plant manufacturing active substances operates in compliance with EU GMP or with equivalent rules, and is subject to equivalent rules for control and inspections. The second option is that the third country has been listed by the European Commission as a country with an equivalent system of supervision and inspection as in the EU. Under the third option, the regulatory authority has consented that only where necessary to ensure the availability of medicinal products, the need for the written confirmation could be waived if the specific manufacturing plant has been inspected by the competent authority of a Member State.
Nevertheless, by July 2, 2013 implementation deadline, some authorities of active substance exporting countries may not be in a position either to issue the written statements or to apply for and be assessed as having an equivalent system of supervision to be included on the Commission's list, said the regulatory authority.
For this, the MHRA, as the rapporteur for the work stream of the heads of Medicines Agencies' Task Force for harmonised implementation of the Falsified Medicines Directive, has led the mapping of source manufacturers of active substances imported into the EU for manufacture into non-centrally authorised medicines for human use. The objective is to minimize the risk of potential shortages of human medicines by identifying high risk suppliers which may need to be inspected in accordance with the three options. It would help to prioritize and coordinate these inspections, together with those for centrally authorised products, on an EU-wide basis.
On this basis, the MHRA will shortly be contacting UK-based Market Authorization (MA) holders to request data on active substance imported into the UK for manufacture.
Indian pharma companies have a major presence in the European Union including EEA. There are also many companies which have production bases in the region. For instance in Karnataka, Strides Arcolab has a manufacturing unit at Warsaw in Poland and Kemwell a dedicated contract manufacturing has a unit in Uppsala, Sweden which are GMP compliant and ready for the new adoption of Directive 2011/62/EU.