Ravimi teisese müügiloa taotlemine
in forcefrom 17.02.2024· RT I, 14.02.2024, 4· Sotsiaalminister
Official English translation: List of documents subject to submission for licence for parallel import in respect of a medicinal product, and the conditions and procedure for processing of applications · RT V, 28.03.2016, 11
The official English translation is published in Riigi Teataja for information. Only the Estonian text has legal force.
The translation is of the version in force from 24.04.2010, not of the current one. Provisions whose Estonian text has changed since are marked. The Estonian text prevails.
Translation in Riigi Teataja ↗Contents
Click the dot before a section, subsection or point: exact citation, link, explanation, wording history, case law and notes.
§ 1. Üldsätted
Määrus kehtestab inimtervishoius kasutatavate ravimite teisese müügiloa taotlemiseks esitatavate dokumentide ja andmete loetelu ning taotluse menetlemise tingimused ja korra.
Määruses kasutatakse mõisteid järgmises tähenduses:
paralleelne sissevedu on Eestis kehtivat müügiluba omava ravimi sissevedu Euroopa Majanduspiirkonna liikmesriigist mõne teise sissevedaja poolt, kui on määranud esmase müügiloa hoidja;
otseselt sisseveetav ravim on Eestis kehtiva müügiloaga ravim, mis on paralleelselt sisseveetava ravimi viidatav ravim;
päritolumaa on Euroopa Majanduspiirkonna liikmesriik, millest paralleelselt sisseveetav ravim on Eestisse toodud ning kus nimetatud ravimil on kehtiv müügiluba.
The Estonian text of this provision has changed since the translated version (24.04.2010): the translation does not match the text in force.
§ 1. General provisions
(1) This Regulation establishes the list of documents subject to submission for licence for parallel import in respect of a medicinal product, including the form for the application for a licence for parallel import, and the conditions and procedure for processing of applications.
(2) For the purposes of this Regulation, the following definitions shall be used:
1) parallel import - the import, from an EEA Member State, of a medicinal product which has a valid marketing authorisation in Estonia, by an importer other than the importer designated by the holder of the first marketing authorisation;
2) directly imported medicinal product - a medicinal product that has a valid marketing authorisation in Estonia and serves as the reference medicinal product for the parallel-imported medicinal product;
3) source country - an EEA Member State from where the parallel-imported medicinal product originates and where the medicinal product has a valid marketing authorisation.
§ 2. Ravimi teisese müügiloa taotlemiseks esitatavad andmed ja dokumendid
Teisese müügiloa taotlemiseks tuleb Ravimiametile esitada järgmised andmed ja dokumendid:
Ravimiameti veebilehel avaldatud vormis taotlus, mis sisaldab taotleja andmeid, paralleelselt sisseveetava ravimi administratiivseid andmeid, müügiloa andmeid päritolumaal, otseselt sisseveetava ravimi müügiloa andmeid ja võimalikke erinevusi ravimite vahel;
ülevaade ümberpakendamise ja märgistamise protsessist, kvaliteedinõuetest ja nende kontrollimise meetoditest;
paralleelselt sisseveetava ravimi pakendi eestikeelne märgistus, sealhulgas märge, kui taotleja soovib erandkorras vabastust Eestis müügile tuleva ravimi sisepakendi ümbermärgistamisest;
ravimi omaduste kokkuvõte ja pakendi infolehe kavand eesti keeles elektroonselt.
Teisese müügiloa taotlemiseks tuleb eesti või inglise keeles täidetud taotlus esitada Ravimiameti veebilehel avaldatud vormis.
Ravimi teisese müügiloa taotlus esitatakse iga ravimi ja iga päritolumaa kohta eraldi.
The Estonian text of this provision has changed since the translated version (24.04.2010): the translation does not match the text in force.
§ 2. Documents subject to submission for licence for parallel import in respect of a medicinal product
(1) To apply for the licence for parallel import, the following documents shall be submitted to the State Agency of Medicines:
1) an application in the form provided in the Annex to this Regulation, filled out in Estonian or English;
2) a copy of the contract complying with the requirements stipulated in the rules for manufacture of medicinal products established on the basis of subsection 16 (8) of the Medicinal Products Act, if the re-packaging and labelling is carried out by another company serving as a contractor;
3) a sample of the parallel-imported medicinal product, along with a copy of the package leaflet from all source countries and, if the product is to be re-packaged into a new inner or outer packaging, a sample of the re-packaged product;
4) a summary of the product characteristics complying with the requirements established on the basis of clause 65 (12) 1) of the Medicinal Products Act, draft design of the packaging and the package leaflet on a hard copy and in electronic form, in both Estonian and English.
(2) The application for a licence for parallel import in respect of a medicinal product shall be submitted separately for each proprietary medicinal product and source country.
(3) For renewal of the licence for parallel import, an application shall be submitted in the form provided in the Annex to this Regulation.
§ 3. Teisese müügiloa taotluse menetlemine
Teisese müügiloa taotlust menetletakse «Ravimiseaduses» ja selle § 65 lõike 12 punkti 3 alusel kehtestatud tingimustel ja korras.
Translation of the version of 24.04.2010; the Estonian text of this provision has not changed since.
§ 3. Processing of application for licence for parallel import
The application for a licence for parallel import shall be processed on the conditions and pursuant to the procedure provided in clause 65 (12) 3) of the Medicinal Products Act.
§ 4. Määruse jõustumine
Määrus jõustub 2005. a 1. märtsil.
The Estonian text of this provision has changed since the translated version (24.04.2010): the translation does not match the text in force.
§ 4. Entry into force of the Regulation
This Regulation shall enter into force on 1 March 2005.