Iščem...
Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: en > sl
1–50/130
guides to good practice
1 Objavljeno
RS
Ur. l. RS, št. MP 39
- sector guidelines not elaborated and establishment of systems of good practices in all individual elements of food chain (good agricultural practice, good manufacturing practice, good hygiene practice), and upgrading the internal control systems according to principles of the HACCP system;
- neizdelane panožne smernice in vzpostavljenje sistemov dobrih praks v vseh posameznih delih živilske verige (dobra kmetijska praksa, dobra proizvodna praksa, dobra higienska praksa) ter nadgradnja sistemov notranjega nadzora na osnovah načel HACCP sistema;
2 Končna redakcija
CELEX: 32004L0027
"(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.
“(f) upoštevati načela in smernice dobre proizvodne prakse za zdravila in uporabiti kot vhodne snovi samo zdravilne učinkovine, ki so bile izdelane v skladu s podrobnimi smernicami dobre proizvodne prakse za vhodne snovi.
3 Končna redakcija
CELEX: 31999L0092
Member States shall, on request, endeavour to make relevant information available to employers in accordance with Article 11, with particular reference to the guide of good practice
Države članice si prizadevajo, da so delodajalcem na njihovo zahtevo na voljo ustrezne informacije v skladu s členom 11, s posebnim sklicevanjem na navodila dobrega ravnanja.
4 Končna redakcija
CELEX: 32004L0027
Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice shall be issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice as provided for by Community legislation.
V 90 dneh od inšpekcijskega pregleda iz odstavka 1 se izdelovalcu izda certifikat dobre proizvodne prakse, če rezultat inšpekcijskega pregleda pokaže, da izdelovalec izpolnjuje načela in smernice dobre proizvodne prakse iz zakonodaje Skupnosti.
5 Končna redakcija
CELEX: 32004L0028
Within 90 days after an inspection as referred to in paragraph 1, a certificate of good manufacturing practice shall be issued to the manufacturer if the inspection established that the manufacturer in question is complying with the principles and guidelines on good manufacturing practice as provided for by Community law.
V 90 dneh po inšpekcijskem pregledu iz odstavka 1 se izdelovalcu izda potrdilo o dobri proizvodni praksi, če se s pregledom ugotovi, da zadevni izdelovalec spoštuje načela in smernice dobre proizvodne prakse, kakor je določena v zakonodaji Skupnosti.
6 Končna redakcija
CELEX: 32004L0027
in Article 47, the following paragraphs shall be added:"The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines.
v členu 47 se dodajo naslednji odstavki: “Načela dobre proizvodne prakse za zdravilne učinkovine, uporabljene kot vhodne snovi iz točke (f) člena 46, se sprejmejo v obliki podrobnih smernic.
7 Končna redakcija
CELEX: 32004L0028
The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 44(1), the reports referred to in Article 80(3) and the form and content of the certificate of good manufacturing practice referred to in Article 80(5).";
Komisija objavi tudi smernice o obliki in vsebini dovoljenja iz člena 44(1), poročilih iz člena 80(3) ter obliki in vsebini potrdila o dobri proizvodni praksi iz člena 80(5).";
8 Končna redakcija
CELEX: 32004R0851
Such assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance and mobilising and coordinating investigation teams.
Takšna pomoč lahko zajema pomoč Komisiji in državam članicam pri razvoju tehničnih smernic dobre prakse in ukrepih zaščite, ki jih je treba izvesti ob nevarnostih za zdravje pri ljudeh, zagotavljanje strokovne pomoči in mobiliziranje in usklajevanje preiskovalnih enot.
9 Končna redakcija
CELEX: 32004L0027
The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 40(1), on the reports referred to in Article 111(3) and on the form and content of the certificate of good manufacturing practice referred to in Article 111(5).";
Komisija tudi objavi smernice o obliki in vsebini dovoljenja iz člena 40(1), o poročilih iz člena 111(3) ter o obliki in vsebini certifikata dobre proizvodne prakse iz člena 111(5).”;
10 Končna redakcija
CELEX: 32004L0028
in Article 51, the following paragraphs shall be added:"The principles of good manufacturing practice as regards the manufacturing of active substances for use as starting materials as referred to in Article 50(f) shall be adopted in the form of detailed guidelines.
v členu 51 se dodata naslednja odstavka: "(f) načela dobre proizvodne prakse za izdelavo zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi iz člena 50(f), se sprejmejo v obliki podrobnih smernic.
11 Končna redakcija
CELEX: 32004L0027
If the outcome of the inspection as referred to in paragraph 1 is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice as provided for by Community legislation, the information shall be entered in the Community database as referred to in paragraph 6.";
Če rezultat inšpekcijskega pregleda iz odstavka 1 pokaže, da izdelovalec ne izpolnjuje načel in smernic dobre proizvodne prakse iz zakonodaje Skupnosti, se te informacije vnesejo v podatkovno bazo Skupnosti, kot določa odstavek 6.”;
12 Končna redakcija
CELEX: 32004L0028
If the outcome of the inspection as referred to in paragraph 1 is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice as provided for by Community legislation, the information shall be entered in the Community database as referred to in paragraph 6.";
Če izidi inšpekcijskega pregleda iz odstavka 1 pokažejo, da proizvajalec ne spoštuje načel in smernic dobre proizvodne prakse, kakor je določena v zakonodaji Skupnosti, se ta informacija vnese v zbirko podatkov Skupnosti iz člena 6.";
13 Končna redakcija
CELEX: 32004L0028
The authorised representatives of the competent authority shall report after each of the inspections mentioned in paragraph 1 on whether the principles and guidelines on good manufacturing practice referred to in Article 51 or, where appropriate, the requirements set out in Title VII, are being complied with.
Pooblaščeni predstavniki pristojnega organa po vsakem inšpekcijskem pregledu iz odstavka 1 poročajo, ali se spoštujejo načela in smernice dobre proizvodne prakse iz člena 51 ali, kadar je to primerno, zahteve iz naslova VII.
14 Končna redakcija
CELEX: 32004L0027
After every inspection as referred to in paragraph 1, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down in Article 47 or, where appropriate, with the requirements laid down in Articles 101 to 108.
Po vsakem inšpekcijskem pregledu iz odstavka 1, uradne osebe, ki predstavljajo pristojni organ, poročajo, ali izdelovalec ravna po načelih in smernicah dobre proizvodne prakse, določene v členu 47, ali, če je to ustrezno, z zahtevami iz členov 101 do 108.
15 Končna redakcija
CELEX: 32004L0027
The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47.
Pristojni organ lahko opravi nenapovedane inšpekcijske preglede tudi v prostorih izdelovalcev zdravilnih učinkovin, uporabljenih kot vhodne snovi, ali v prostorih imetnikov dovoljenja za promet z zdravili, če so mnenja, da obstajajo razlogi za sum o neupoštevanju načel in smernic dobre proizvodne prakse iz člena 47.
16 Pravna redakcija
promet
Guide to good distribution practice (94/C 63/03);
Priročnik o dobri distribucijski praksi (94/C 63/03),
Prevodi: en > sl
1–50/130
guides to good practice