Initial classification of the GMM

Of 21,664 sonographically evaluated hips, 78% were mature at the initial examination, 20% were type II a /according to Graf classification/ and 2% were unstable.

Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.";

- the initial classification is higher than the activity warrants and accordingly a lower classification with its attendant containment conditions would be appropriate.

In considering the final classification and containment measures, the initial classification should be revisited to determine if it was correct bearing in mind the activities and characteristics of the operations proposed.

- the initial classification was correct and the attendant containment measures adequately prevent or minimise harm to human health and the environment,

The research programme might also investigate further improvement of the classifications for those products for which an initial classification is given below.

A comparison of the initial classification and associated containment measures with the final class and containment requirements can give rise to three results:

Commission Decision of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13)

Points 3 to 5 of Annex III indicate that the first stage of the risk assessment process for a GMM is to identify the potential harmful properties of the GMM, to determine an initial classification for the GMM.

When all potentially harmful characteristics have been reviewed for their severity and possibility of occurrence, with the effect of the containment and control measures indicated by the initial classification of the recipient considered, the final classification and containment measures for the GMM can be determined.

- there are harmful effects which are not adequately taken into account in the initial classification, these would not be adequately contained by the provisional containment considered under Procedure 1. This would require the application of additional containment measures and possibly revision of the classification of the activity,

Commission Decision of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (notified under document number C(2000) 938) (Text with EEA relevance)

The possibility of humans or the environment being exposed to a GMM depends upon what operations are being carried out (for example the scale of the operations) and the containment measures appropriate to the initial classification as determined in points 5 and 6 applied to the work.

'Initial coverage of goods and services of the HICP` is defined as those four-digit categories and sub-categories specified in the classification COICOP/HICP (classification of individual consumption by purpose adapted of the needs of HICPs) given in Annex I.

whereas the Commission will initiate the procedure for the entry into force of rules for the production of gelatine derived from ruminant bones without delay after the adoption of Community legislation concerning classification of countries or regions as regards their BSE status;

Initial installation of SYSTEMS and any major change thereto shall be so specified that installation is carried out by security cleared installers under constant supervision by technically qualified personnel who are cleared for access to EU classified information to the level equivalent to the highest classification which the SYSTEM is expected to store and handle.

the initial classification is higher than the activity warrants and accordingly a lower classification with its attendant containment conditions would be appropriate.

the initial classification was correct and the attendant containment measures adequately prevent or minimise harm to human health and the environment,

Commission Decision of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers

there are harmful effects which are not adequately taken into account in the initial classification, these would not be adequately contained by the provisional containment considered under Procedure 1.

Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13)."

Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers(2) is to be incorporated into the Agreement,

Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.";

A multi-centre, phase II, open-label, non-comparative study of clofarabine was conducted to determine the overall remission (OR) rate in heavily pretreated patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL defined using the French-American-British classification.

on its own initiative or on request, to furnish information or guidance on any matters concerning the classification of goods in the Harmonized System to Contracting Parties, to Members of the Council and to such intergovernmental or other international organizations as the Committee may consider appropriate;

The identification of lay-offs (unpaid leave initiatied by the employer) and their classification as employed (or unemployed) persons depends on two conditions of a formal job attachment: an assurance of return to work after the end of the contingency and the short duration (< =3 months) of the suspension of the labour contract.

Initial installation of systems and any major change thereto shall be so specified that installation is carried out by security cleared installers under constant supervision by technically qualified personnel who are cleared for access to EU classified information to the level equivalent to the highest classification which the system is expected to store and handle.

Where a classification decision adopted in accordance with the Community procedures in force referred to in Article 5 of this Annex involves a category of products subject to a quantitative limit, the Commission shall, without delay, initiate consultation in accordance with Article 16 of the Regulation, in order to reach agreement on the necessary adjustments to the corresponding quantitative limits provided for in Annex V.

Where a classification decision adopted in accordance with the Community procedures in force referred to in Article 5 of this Annex involves a category of products subject to a quantitative limit, the Commission shall, without delay, initiate consultation in accordance with Article 16 of the Regulation, in order to reach agreement on the necessary adjustments to the corresponding quantitative limits provided for in Annex II.

Where a classification decision adopted in accordance with the Community procedures in force referred to in Article 5 of this Annex involves a product group subject to a quantitative limit, the Commission shall, where necessary, initiate consultations without delay in accordance with Article 9 of this Decision, in order to reach agreement on any necessary adjustments to the corresponding quantitative limits provided for in Annex IV.

On the initiative of the Commission or of a Member State, the Nomenclature Committee which was established by Council Regulation (EEC) No 2658/87 (1), which will examine urgently in conformity with the provisions of the aforementioned Regulations, all questions concerning the classification of products referred to in Article 1(1) of the Regulation within the combined nomenclature (CN) in order to classify them in the appropriate categories.

It is therefore appropriate, as an initial step, to harmonize the basic principles applicable to the classification for the supply of medicinal products in the Community or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonization completed within the framework of the United Nations, concerning narcotic and psychotropic substances.

On the initiative of the Commission or of a Member State, the tariff and statistical nomenclature section of the Customs Code Committee, which was established by Council Regulation (EEC) No 2658/87 (1) will examine urgently in conformity with the provisions of the abovementioned Regulations, all questions concerning the classification of products referred to in Article 1 (1) of the Regulation within the combined nomenclature (CN) in order to classify them in the appropriate categories.

On the initiative of the Commission or of a Member State, the tariff and statistical nomenclature section of the Customs Code Committee, which was established by Council Regulation (EEC) No 2658/87(1), as amended by Article 252 of Council Regulation (EEC) No 2913/92(2), will examine urgently, in accordance with the provisions of the abovementioned Regulations, all questions concerning the classification of products covered by this Decision within the Combined Nomenclature in order to classify them in the appropriate product groups.