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Instruction No. 111/31.03.2010 (on supplementary protection certificates for medicinal products), Romania

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Latest Version in WIPO Lex
Details Details Year of Version 2010 Dates Adopted: March 31, 2010 Type of Text Implementing Rules/Regulations Subject Matter Patents (Inventions), Plant Variety Protection, Enforcement of IP and Related Laws, IP Regulatory Body

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Main text(s) Main text(s) Romanian Instructiuni nr. 111/31.03.2010 (certificat suplimentar de protectie pentru medicamente)        

OFICIUL DE STAT PENTRU INVENTII SI MARCI

Strada Ion Ghica nr.5, Sector 3, Bucuresti -Cod 030044 –ROMANIA

Telefon centrala: +40-21-306.08.00/01/021. .. ./28/29

Telefon Secretariat: +40-21-315.90.66

Fax: +40-21-312.38.19

office@osim.ro

Cod fiscal: 4266081

Cont OSIM: R089TREZ7005025XXX000278

Instructiune nr. 111 /11.03.2010

Avand in vedere ca, incepand cu ianuarie 2007, OSIM aplica prevederile Regulamentului CE nr. 1901/2006 al Parlamentului European si al Consiliului din 12 decembrie 2006 privind medicamentele de uz pediatric si ale Regulamentului (CEE) nr. 1768/92, amendat si republicat in 26.01.2007 privind crearea unui certificat suplimentar de protectie pentru medicamente;

Tinand cont de faptul ca aplicarea aquis-lui comunitar in domeniul .mentionat este impusa ulterior ultimei modificari si completari in anul 2005 (prin Legea 381/2005) a OG 41/1998 si ca aceasta nu contine taxe cu destinatie expresa pentru aplicarea prevederilor Regulamentului CE nr. 1901/2006 privind medicamentele de uz pediatric;

Luandu-se in considerare similitudinea procedurii privind certificatul suplimentar de protectie cu procedura privind extinderea duratei certificatului suplimentar de protectie;

In vederea asigurarii indeplinirii obligatiilor ce revin OSIM, in conformitate cu art. 9 alin. 1, ca autoritate competenta pentru inregistrarea si acordarea Certificatelor suplimentare de protectie si a Extinderii duratei certificatului suplimentar de protectie pentru medicamente pediatrice, si in aplicarea art. 8 alin.2 din Regulamentului (CEE) nr. 1768/92, amendat si republicat in 26.01.2007,

In temeiul art. 6(3) din H.G. 573/1998 privind organizarea si functionarea OSIM, modificata prin H.G. 1396/18.18.2009, Directorul General al OSIM emite urmatoarea Instructiune:

Instructiune ART.1 Se completeaza Art.6 al Instructiunii nr. 146/28.12.2006 privind certificatul suplimentar de protectie pentru medicamente si certificatul suplimentar de protectie pentru produse de protectia plantelor cu doua noi alineate (6) si (7) cu urmatorul continut:

  1. Taxele pentru inregistrarea si examinarea cererii de extindere a duratei certificatului suplimentar de protectie, asimilate celor prevazute in Anexa 1, punctul 24 din OG 41/1998 privind taxele in domeniul protectiei proprietatii industriale, modificata si completata de Legea 381/2005, publicata in Monitorul Oficial nr. 6 din 04 ianuarie 2006.
  2. Pentru durata de 6 luni de extindere a duratei certificatului suplimentar de protectie pentru medicamente, acordata cu respectarea Regulamentului (CEE) nr. 1768/92, amendat si republicat in 26.01.2007, taxa va fi asimilata cu taxa aferenta anului 5 sde mentinere in vigoare a certificatului suplimentar de protectie, prevazuta in Anexa 1, punctul 25 din OG 41/1998 privind taxele in domeniul protectiei proprietatii industriale, modificata si completata de Legea 381/2005, publicata in monitorul Oficial nr. 6 din 04 ianuarie 2006.

Legislation Amends (1 text(s)) Amends (1 text(s)) Relates to (3 text(s)) Relates to (3 text(s))
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WIPO Lex No. RO062