Medicines
Hitherto, EU law has in effect made provision for two different procedures when registering medicinal products (i) registration with the competent authority in the member state (for instance, following the accession of CR to the EU, by the Medicinal Products State Inspection Office in the CR) and (ii) registration via a centralised evaluation body (European Medicines Evaluation Agency, London).
The two new regulations set out the steps for variations in marketing authorisations applicable under both procedures. The intention is to simplify and expedite procedures for certain types of variations in registration, as well as to clarify legislation in this area. Upon registration in a member state, the variation will be examined by a competent authority of the member state. Provisions governing administrative procedures and requirements for variation of registration will differ according to the type of variation, as set out in the attached schedules. Procedures have been simplified, particularly where there is a need to adopt emergency measures or to combat an influenza pandemic.
Commission Directive 2003/94/EC of 8 October 2003 setting out the principles and guidelines for good manufacturing practice relating to medicinal products for human use
Official Journal of the EU L 262 of 14 October 2003
This Directive introduced a change in the requirements relating to correct manufacture of medicinal products intended for human use and replaces existing Directive 91/356/EEC. It incorporates new provisions on the rights of supervisory bodies to carry out inspections, quality control and other matters requiring attention following experience in implementing the existing provisions. At national level the Directive is mostly reflected in secondary legislation. The deadline for implementation of the Directive into national legal order expires on 30 April 2004.
Other articles
KŠB assisted Seyfor with the extension of its financing provided by Raiffeisenbank, Tatra banka and, newly, Slovenská sporiteľňa.
The KŠB team provided legal advice to its long-standing client Seyfor in connection with the continuation and expansion of its syndicated financing. The existing lending banks, Raiffeisenbank Czech Republic and Tatra banka, decided to continue supporting Seyfor’s growth, with Slovenská sporiteľňa joining the financing as a new lender.
Evidence skutečných majitelů: Co přinese znepřístupnění od 17. prosince 2025?
Letošní rozhodnutí Nejvyššího soudu a Nejvyššího správního soudu navázala na rozsudky Soudního dvora Evropské unie, a, s platností i pro Českou republiku, konstatovala, že zveřejňování údajů v rámci evidence skutečných majitelů představuje nepřiměřený zásah do základních práv majitelů na soukromí a ochranu osobních údajů. Důležitým aspektem těchto rozhodnutí byl závěr, že sankce, které postihují povinné subjekty jako reakce na nesplnění jejich povinnosti zápisu do evidence skutečných majitelů, není možné vymáhat, dokud je evidence veřejná. Tato situace se změní 17. prosince 2025, kdy ministerstvo znepřístupní evidenci skutečných majitelů; povinným subjektům tak budou opět hrozit závažné sankce.
30th Advent Concert for the Committee of Good Will – Olga Havlová Foundation
This year again, during the pre-Christmas season, the Advent Concert of Good Will took place. Since 1995, it has been organised by the law firm Kocián Šolc Balaštík in support of the Committee of Good Will – Olga Havlová Foundation. This was already the 30th anniversary edition, made exceptional by the fact that we organised it for the first time together with our partner, Smetanova Litomyšl, as part of a broader mutual cooperation. As always, the concert was held in the concert hall of the Church of Sts. Simon and Jude in Prague’s Old Town.
