14/15 December 2021
The European Commission is currently revising the 'Guideline on Good Distribution Practice of Medicinal Products for Human Use". The current Guideline was first published in 1994. The new revision is very comprehensive. Nearly all sections have been changed. A detailed analysis of the Draft Good Distribution Guideline was published in our GMP News.
In the meantime, authorities, associations and industry have sent comments to the EU Commission. The large number of comments indicates that the revision will have a major impact on pharmaceutical companies, wholesalers and logistic companies. Even the authorities like the German Federal Ministry of Health, the Austrian Authority AGES and the Danish Medicine Agency have sent their comments to the EU Commission.
The new GDP Guideline is intended to come into force in June/July 2012. The key function of the so called Responsible Person will be strengthened. The current draft requires from the Responsible Person to be permanently available. The organisation chart, the job descriptions and the training requirements are now more precisely defined.
The Responsible Person will become the key position for GDP - as the Qualified Person is for GMP. So far, many companies have named a Responsible Person but without selection and training requirements. In the new text it is stated that the company should give the Responsible Person "the authority, resources and responsibility needed to fulfil his/her duties".
Also the qualification of the Responsible Person will lead to discussions. In the current draft it is defined: "The qualifications of the Responsible Person should meet the conditions provided by the legislation of the Member State concerned and should be appropriate to fulfil the assigned duties. A degree in Pharmacy is desirable. He/she should have appropriate competence and experience as well as knowledge and training on GDP."
But what would be the alternative to a degree in Pharmacy? How about other studies in natural sciences like Chemistry and Biology? How about experienced colleagues without such a degree? A number of organisations have posted comments on this newly proposed requirement. Most of the stakeholders recommend making this requirement more flexible in order to allow experienced personnel to take over the responsibility. All in all, good qualification and training will be a prerequisite. The main responsibilities of the Responsible Person are listed under section 2.5.:
"His/her responsibilities include, but are not limited to:
i) ensuring that a quality management system is implemented and maintained;
ii) focussing on the management of authorised activities and the accuracy and quality of records;
iii) approving the initial and continuous training programme for all personnel involved in distribution activities;
iv) coordinating and performing promptly any recall operations of medicinal products;
v) ensuring that relevant customer complaints are dealt with effectively;
vi) performing the qualification and approval of suppliers and customers;
vii) authorising the return to saleable stock of any returned medicines;
viii) approving any contract between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of medicinal products;
ix) ensuring that self inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
x) delegating his/her duties when absent and keeping appropriate records relating to any delegation;
xi) being involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products;
xii) ensuring that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC".
The ECA is therefore organising a Training Course for the Responsible Person for Good Distribution Practices (GDP) in Berlin on 5 - 6 December. There, speakers from both industry and authority will provide information about the role and the responsibility of the Responsible Person.
Revised Guideline on Good Distribution Practice of Medicinal Products for Human Use (Draft)
Current Guideline on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)