Examples of using Spcs in English and their translations into Swedish
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Ecclesiastic
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Official/political
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Computer
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Programming
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Political
Commission services and SPCs.
The following sections of the SPCs were presented for harmonisation.
Commission services in co-operation with SPCs.
at least the SPCs, should be presented in English.
Commission services, Focal Points and SPCs.
SPCs are to be made up of councillors
Contraindications There are contraindications present in one or several local SPCs.
The divergences that previously existed across the SPCs of EU Member States included.
Findings of the Court First abuse of a dominant position concerning the SPCs.
SPCs are an intellectual property right that serves as a time-limited extension to a patent right.
Pharmaceutical regulatory affairs including EMA templates such as PILs and SPCs.
Many SPCs of nationally authorised products may differ in some respects between Member States.
It is noted that a daily dose of 2 X 15 mg/ kg bw is recommended in several SPCs.
The SPCs are published in Finnish;
The CHMP noted that there were contraindications present in one or several local SPCs.
Although this practise is endorsed in some existing EU SPCs, the CHMP considers that the data are very limited.
Almost all maritime Member States and Norway and Poland have national Short Sea Promotion Centres SPCs.
All other sections of the SPCs will be harmonised as approved in the Mutual Recognition Procedure.
Those representations in fact prompted those patent offices to issue SPCs on the basis of that date.
Revised SPCs and PLs provide updated information in relation to best use of the product considering latest clinical data.
Extending the scope of Shortsea Promotion Centres(SPCs) to multimodality in inland logistics solutions- new action.
Accordingly, the Commission is planning to expand its Horizontal Guidelines to also address SPCs for all sectors.
This lack of harmonisation could result in discrepancies between the SPCs of the originator and the generic product on the same national market.
Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
Harmonised SPC is not so dissimilar to the currently approved SPCs that it will significantly change clinical practices.
However, the wording(and therefore the precise meaning) of the indication is very different in the nationally approved SPCs.
The SPCs proposed by the MAH were those approved through the MRP in the"old" member states and in CY and IS.
SPC Section 4.3- Contraindications The MAH was asked to harmonise Section 4.3, for which the following differences between SPCs needed to be evaluated.
The CHMP noted that some of the contraindications in local SPCs(such as acute hypertension
for which the following differences between SPCs needed to be evaluated.