National Approval Authorities

National approval authorities in some countries hesitate to approve Bt preparations because of the similarities between B. thuringiensis and the pathogenic species B. anthracis and B. cereus. However, no ecotoxicological or human toxicity seems to be associated with Bt itself or its toxins. The half-life in soil is short, and it is destroyed by sunlight. The questions about possible ecological consequences of Bt plants are not yet settled. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

Hypoalgesia ICH (International Conference on Harmonization) Diminished sensitivity to a noxious stimulation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to harmonise scientific and technical aspects of product registration. They make recommendations which will be adopted by the national / EU authorities after an approval process. 

Approval of the importer. Provided that the above is satisfactory, the national control authority then notifies the importer that the import of the product has been authorised. Only after receipt of this authorisation can the importer import and market the product. A copy also goes to the body certifying the importer. 

Until the end of 1992, the multistate procedure, which also relied on a mutual recognition of national approvals, operated on a very similar basis and has been very disappointing. Objections against the initial assessment and approval as well as against CPMP opinions were not exceptions, but the rule. The introduction of time limits for the evaluation and responses by the national authorities must also be considered as illusory. The average period to grant or refuse a national licence, after the CPMP opinion was formulated, varied between six months in Luxembourg and 26 months in Italy (Charlesworth, 1992). The limitation for this step was initially 30 days and was subsequently extended to 60 days ... 

The Decentralized Procedure is made on the basis of mutual recognition. Council Directive 93/39/EEC has been implemented in all member states in accordance with Directives 65/65/EEC and 75/319/ EEC. The sponsor makes a submission to the national health authority of one member state, with a request to assess the dossier for mutual recognition. Within 210 days, the so-called Reference Member State (RMS) must approve the application, prepare an assessment report, and agree on an SPC. The clock may be stopped to obtain further information during this time. 

In addition to national approvals and lists, a pharmaceutical licensing authority can impose additional restrictions at the time of application review. Within the EU this generally takes the form of restricting colors, such as tartrazine and other azo colors, in medicinal products for chronic administration, and especially in medicines for allergic conditions. 

Non-promotional information for patients and the general public Subject to any applicable national laws and regulations, websites may include non-promotional information for patients and the general public on products distributed by the company (including information on their indications, side effects, interactions with other medicines, proper use, reports of clinical research, etc.), provided that such information is balanced, accurate and consistent with the approved summary of product characteristics (SPC). For each product that is discussed, the website must contain full, unedited copies of the current SPC and patient leaflet. These documents should be posted in conjunction with other information about the products or be connected with that discussion by a prominent link advising the reader to consult them. In addition, the website may provide a link to the full, unedited copy of any public assessment report issued by the Committee for Medicinal Products for Human Use or a relevant national competent authority. Brand names should be accompanied by recommended international non-proprietary names (rINNs). 

Most of the work of the national regulatory authorities concern license variations, line extensions and license renewals. The application will follow the same approval procedure in which the original authorization was obtained. As many products currently licensed have been licensed through national procedures, before the mutual recognition or CP were available, many of the applications are still undergoing the national approval process in each MS separately. 

In programming chemical expansion and in studying supplies and requirements of chemicals, statistics are essential. Production statistics are obtainable through federal agencies, but data on plant capacities, uses, and raw material requirements are also necessary. Such data were developed by the Chemical Division of the National Production Authority on officially approved forms, which were sent to chemical producers. By the end of 1951,92 specific chemicals were surveyed, analysis of data is in progress regularly, and results of such analyses are put to immediate use by the various chemical specialists. 

Biocide active substances or products are generally exempt from REACH evaluation and authorization procedures because they are regulated in the EU under the Biocidal Products Directive (BPD) (EC 1998). This Directive has an established process for evaluation of active substances (for listing in Annex I of the BPD), followed by national approvals of the formulated biocidal products containing them. However,... 

For drugs of limited geographic interest and for all generics, companies would continue to apply to national regulatory authorities for approval to market only within that country (67,210). 

A special part of their work consists of a continuous review of the pharmaceutical legislation to improve the communication between the pharmaceutical industry and the approving authorities, as well as the harmonization and communication between national and EU authorities. 

As a consequence of the new legislation for clinical trials, documentation on the quality and preclinical (i.e., toxicological) data of investigational medicinal products, including radiopharmaceuticals, needs to be submitted to obtain approval from the national health authorities in the member states prior to initiating a clinical study in humans. Furthermore, all clinical trials which started in the European Union after 1 May 2004 need to be recorded in the European EudraCT database (European Commission 2003 b). 

The names and qualifications of those responsible for approving lot processing records (protocols) should be registered with the national control authority. 

The information given on the label on the container and the label on the package shall be approved by the national control authority. 

The records shall be of a type approved by the national control authority. They shall be retained for at least two years after the expiry date of a lot or batch of a biological product and be available at all times for inspection by the national control authority. 

Recommended MRLs will be proposed to the national standard authority for approval. 

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