The Registration Dossier

REACH requirements for substances, mixtures, and articles do not apply to waste itself. Nevertheless manufacturers and importers of substances, downstream users and potentially recipients of articles have a number of duties under REACH related to substances in waste. Waste-related information must be included in the registration dossier for all substances, including those for which no CSR and/or SDS3 is required (<10 tla) or which are not classified as dangerous. [19]. 

The general technical, commercial and administrative information for the registration dossier is specified in Annex IV of the proposed REACH Regulation (Table 16). 

The two most contentious aspects of REACH have been the registration requirements and the authorization process. While no one has argued that substances should not have to be registered, there have been many arguments about the amount of data that must be submitted in the registration dossiers and about how to deal with substances contained in manufactured articles imported from outside the EU. The public availability of information has also been an issue. The focus of the debate about authorization was whether authorizations should be granted where an alternative was available. The debate here can be seen as an argument between risk-based and precautionary approaches. 

The registration dossier is sent to ECHA, which reviews the registrations and, if necessary, demands supplementary information. ECHA will however not have the resources to review the quality and accuracy of data of all registrations. 

One copy of the application dossier should be submitted to the Licensing Secretariat of the NDI (Koom 420, Telephone +359 2 944 13 89, Fax +359 2 943 44 87). Upon submission of the registration dossier an application form (Annex 1 of Regulation No. 17) shall be filled out in 3 copies. 

Parts I and II of the registration dossier, identical with that accepted by EMEA. 

Together with the application form specified in para 1, two copies of the registration dossier of the medicinal product shall be submitted, including ... 

The Directives describe the specific structure of the registration dossier. Documentation in the English language is acceptable. Documentation in any other language besides Hebrew has to be translated and notarized. 

The recommended dosage of herbal medicines in Poland is in compliance with the dosage presented in Herbal Monographs, edited by Commission E of the Ministry of Health in Germany. The registration dossier requirements depend on the type of products. Major requirements, published in the Regulatory Affairs Journal, January 1997, for all categories are as follows ... 

For vitamin and mineral products with a lower dose than the Recommended Daily Allowance (RDA), the registration dossier requirements are a little less extensive, which makes the registration procedure quicker. 

A meaningful motivation must be given for the amendment. It is also necessary for the appliccint to supply some history of applicable amendments to the registration dossier. More than 5,550 such changes were processed in 1997. The... 

Format of submissions and points to remember when replying to council resolutions and applying for amendments to the registration dossier... 

Amended circular 18/89 Permitted amendments to the registration dossier (Ann 2-13)... 

Practical procedures—The registration dossier is submitted as outlined previously to the IKS with the stipulated number of copies. A routine control for completeness will be made and the applicant will be notified within about a month if it is satisfactory. If some additional documents are required or if it is significantly incomplete, the dossier will be returned (if it is not completed within 4 months). 

We have assumed that the process study is performed on a laboratory or on a pilot scale, and this is almost invariably the case. This is because it would normally be prohibitively expensive to realise such studies on an industrial scale. Also, the process for a pharmaceutical product is defined in the registration dossier, and it is also validated. There is not a great deal of scope for changing either the conditions or the formulation,... 

Since excipients are not subject to registration or marketing authorization procedure, their manufacturers are not under regulatory obligation to maintain the production processes in accordance with provisions of the registration dossier. Therefore... 

Real-time studies The experimental storage conditions should be as close to the projected actual storage conditions in the distribution system as practicable (see Table 3). For registration purposes, the results of studies of at least 6 months duration should be available at the time of registration. However, it should be possible to submit the registration dossier before the end of this... 

Starting material should only be purchased from approved suppliers and in accordance with the registration dossier. 

The registration dossier should be compliant with Master documentation. 

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