Ohjausta geneerisiin myyntilupahakemuksiin / New functional measures and guidance for generic applications in Finland

The EU-wide regulatory framework within mutual recognition procedures (MRP) is based on the co-operation and sharing of the regulatory workload between 25 EU Member States and 3 EEA countries. The National Agency for Medicines (NAM) is willing to handle its share of the common regulatory workload. However, every national competent authority, as NAM, has limitations to accommodate large and unexpected fluctuations in the number of Marketing Authorisation Applications (MAAs).

During 2003 and 2004 NAM has granted app. 500 national marketing authorisations per year. In 2004, the number of MRP procedures with Finland as reference member state (RMS) has been expanded to over 150 procedures (30 % of all MRP procedures in the EU). Due to the large number of MAAs for generic products during recent months the NAM has currently over 800 pending applications for marketing authorisation. Most applicants are planning a Mutual Recognition Procedure after national authorisation in Finland. A considerable amount of these products are not planned to be marketed in Finland.

There is a serious concern that this extremely heavy workload will definitely lead to delays and longer processing times for all marketing authorisation procedures in Finland. Therefore, NAM is obliged to adjust its functions to cope with the unexpected workload due to MAAs of generic products intended for other markets. According to NAM’s opinion the applicants should submit their future MAAs for generic products primarily to those Member States to which their products are de facto targeted.

As a part of these new functional measures and guidance:

1.   The applicants are asked to provide a list of planned national or decentralised submissions during 2005 to the national marketing authorisation procedure in Finland. The following information should be included to the list if possible:

• Drug substance, strengths and pharmaceutical forms
• Number of Trade names (duplicates)
• Plans for MRP or decentralised procedures (DCP) incl. concerned member states (CMSs) and draft time schedule.

When the NAM is planned to act as the RMS, the applicant should contact prior to the national or decentralised submission in order to draw up a time plan. The contact person is Dr. Jussi Holmalahti, Head of Section to whom further information would be addressed in a written form or by e-mail ([email protected]).

2.   The applicants are asked to provide information concerning the schedule for marketing introduction in Finland for each individual MA (pending MAAs as well as planned submissions). The information is extremely important for NAM to prioritize assessment duties. This information will be also taken account to analyse the consequences of the new so-called “Sunset Clause”[1]coming to operation since 30 October 2005. In the future this may risk the validity of Finnish marketing authorisations and consequently the grounds for Finland to act as RMS for those medicinal products.

3.   The NAM will concentrate to keep the processing time of each individual national authorisation in 210 days. To get more resources for processing of applications in the order of submission, so-called clones or duplexes are not any more processed by fast track. The applicants are asked to take account the chance in the procedure of the NAM in the future submissions.

4.   The applicant can help to cut processing times by submitting complete and well-compiled applications. However, to make the discussions more efficient between the NAM and the applicant, especially in clinical and pharmaceutical issues concerning SPC and PIL, the applicants are asked to provide a contact point of the Finnish/Swedish speaking person authorised for communication with the NAM.

The National Agency for Medicines is committed to contribute and to co-operate in the national and European marketing authorisation procedures in the best possible ways and according to the legislative frameworks. However, the new functional and practical measures and guidance above are regarded necessary for the purpose of keeping the regulatory processes in control and in rational management. 

 

Director General, professor            Hannes Wahlroos

 

Head of Department, professor      Olavi Tokola

 

[1]Marketing authorisation ceased to be valid if product is not marketed within three years or for three consecutive years.

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