Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority'.
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD) Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XIII Medicinal Products
Joint committee decision (JCD)
069/2001 In force in the EEA
Yes Legal documents
Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority'.
Reglugerð framkvæmdastjórnarinnar (EB) nr. 847/2000 frá 27. apríl 2000 þar sem mælt er fyrir um beitingu viðmiðana sem lyf þurfa að uppfylla til að nefnast lyf við fágætum sjúkdómum og skilgreiningar á hugtökunum „samsvarandi lyf“ og „klínískir yfirburðir“
Verordnung (EG) Nr. 847/2000 der Kommission vom 27. April 2000 zur Festlegung von Bestimmungen für die Anwendung der Kriterien für die Ausweisung eines Arzneimittels als Arzneimittel für seltene Leiden und von Definitionen für die Begriffe "ähnliches Arzneimittel" und "klinische Überlegenheit"
Kommisjonsforordning (EF) nr. 847/2000 av 27. april 2000 om fastsettelse av bestemmelser om gjennomføring av kriteriene for utpeking av et legemiddel som et legemiddel mot sjeldne sykdommer og om definisjon av uttrykkene ”lignende legemiddel” og ”klinisk overlegenhet”
History
20.06.2001
Adopted JCD confirmed entry into force date
20.06.2001
Compliance date in the EEA
19.06.2001
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
13.03.2001
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
27.04.2000
Adoption date in the EU
28.04.2000
Compliance date in the EU
Disclaimer: EEA-Lex is provided for information purposes only. The information is not guaranteed or promised to be current or complete and is not intended to replace any applicable legal sources.