natgillin/translations-raw huggingface dataset:
Διαθέσιμα σε Τράπεζες και στο Ταμείο
A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from Chapters Π to V medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility. " [51
Λογαριασμοί τάξεως
AUTHORISATION TO PLACE " MEDICINAL PRODUCTS " [51 ON THE MARKET
('Εκτός αν ή εθνική νομοθεσία προβλέπει την εμφάνιση τους στη θέση Δ Π 6).
The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions. " [10]
ΣΤ.
ARTICLE 4
Βραχυπρόθεσμες υποχρεώσεις (ποσά που είναι πληρωτέα εντός έτους).
IN ORDER TO OBTAIN AN AUTHORISATION TO PLACE A " MEDICINAL PRODUCT " [51 ON THE MARKET AS PROVIDED FOR IN ARTICLE 3, THE PERSON RESPONSIBLE FOR PLACING THAT
'Ομολογιακά δάνεια με διαχωρισμό των μετατρέψιμων σε κεφάλαιο.
The person responsible for placing medicinal products on the market shall be established in the Community.
'Υποχρεώσεις σε πιστωτικά ιδρύματα. 3.
NAME OR CORPORATE NAME AND PERMANENT ADDRESS OF THE PERSON RESPONSIBLE FOR PLACING THE PROPRIETARY PRODUCT ON THE MARKET AND, WHERE APPLICABLE, OF THE MANUFACTURER.
Ληφθείσες προκαταβολές παραγγελιών εφόσον δεν εμφανίζονται αφαιρετικά άπό τα αποθέματα κατά τρόπο σαφή. 4.
QUALITATIVE AND QUANTITATIVE PARTICULARS OF ALL THE CONSTTTUENTS OF THE PROPRIETARY PRODUCT IN USUAL TERMINOLOGY, BUT EXCLUDING EMPIRICAL CHEMICAL FORMULAE, WITH MENTION OF THE INTERNATIONAL NON-PROPRIETARY NAME RECOMMENDED BY THE WORLD HEALTH ORGANISATION WHERE SUCH NAME EXISTS.
Προμηθευτές. 5.
BRIEF DESCRIPTION OF THE METHOD OF PREPARATION.
Γραμμάτια πληρωτέα. 6.
CObHRA-INDICATIONS AND SIDE-EFFECTS.
'Υποχρεώσεις σε συνδεδεμένες επιχειρήσεις. 7.
If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of any potential risks presented by the medicinal product for the environment. " [101
'Υποχρεώσεις σε επιχειρήσεις με τις όποιες υπάρχει δεσμός συμμέτοχης.
DESCRIPTION OF THE CONTROL METHODS EMPLOYED BY THE MANUFACTURER (QUALITATIVE AND QUANTITATIVE ANALYSIS OF THE CONSTTTUENTS AND OF THE FINISHED PRODUCT, SPECIAL TESTS, E.G. STERILITY TESTS, TESTS FOR THE PRESENCE OF PYROGENIC SUBSTANCES, THE PRESENCE OF HEAVY METALS, STABILITY TESTS, BIOLOGICAL AND TOXICITY TESTS, CONTROLS CARRIED OUT AT AN INTERMEDIATE STAGE OF THE MANUFACTURING PROCESS). " [21
Λοιπές βραχυπρόθεσμες υποχρεώσεις περιλαμβανομένων των φόρων και των υποχρεώσεων στις κοινωνικές ασφαλίσεις. 9.
(b) IN THE CASE OF NEW " MEDICINAL PRODUCTS " [51 CONTAINING KNOWN CONSTITUENTS NOT HITHERTO USED DM COMBINATION FOR THERAPEUTIC PURPOSES, THE RESULTS OF PHARMACOLOGICAL AND TOXICOLOGICAL TESTS AND OF CLINICAL TRIALS RELATING TO THAT COMBINATION MUST BE PROVIDED, BUT IT SHALL NOT BE NECESSARY TO PROVIDE REFERENCES RELATING TO EACH INDIVIDUAL CONSTITUENT. " [4J
Λογαριασμοί τάξεως (εκτός αν ή εθνική νομοθεσία προβλέπει την εμφάνιση τους στην θέση Κ).
A SUMMARY, IN ACCORDANCE WITH ARTICLE 4a, OF THE PRODUCT CHARACTERISTICS, ONE OR MORE SPECIMENS OR MOCK­UPS OF THE SALES PRESENTATION OF THE PROPRIETARY PRODUCT, TOGETHER WITH A PACKAGE LEAFLET WHERE ONE IS TO BE ENCLOSED. " [3J
Συνολικό ενεργητικό μείον βραχυπρόθεσμο παθητικό
Details of any decision to refuse authorization, whether in the Community or in a third country, and the reasons for such decision.
Μακροπρόθεσμες υποχρεώσεις (ποσά πληρωτέα πέραν του έτους)
THE SUMMARY OF THE PRODUCT CHARACTERISTICS REFERRED TO IN POINT 9 OF THE SECOND PARAGRAPH OF ARTICLE 4 SHALL CONTAIN THE FOLLOWING INFORMATION:
'Ομολογιακά δάνεια με διαχωρισμό των μετατρέψιμων σε κεφάλαιο.
QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENTS AND CONSTITUENTS OF THE EXCIPIENT, KNOWLEDGE OF WHICH IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE MEDICINAL PRODUCT; THE INTERNATIONAL NON­PROPRIETARY NAMES RECOMMENDED BY THE WORLD HEALTH ORGANIZATION SHALL BE USED, WHERE SUCH NAMES EXIST, OR FAILING THIS, THE USUAL COMMON NAME OR CHEMICAL DESCRIPTION.
Προμηθευτές. 5.
PHARMACOLOGICAL PROPERTIES AND, IN SO FAR AS THIS INFORMATION IS USEFUL FOR THERAPEUTIC PURPOSES, PHARMACOKINETIC PARTICULARS.
Γραμμάτια πληρωτέα. 6.
CLINICAL PARTICULARS:
Λοιπές μακροπρόθεσμες υποχρεώσεις περιλαμβανομένων των φόρων και των υποχρεώσεων στις κοινωνικές ασφαλίσεις. 9.
POSOLOGY AND METHOD OF ADMINISTRATION FOR ADULTS AND, WHERE NECESSARY, FOR CHILDREN, 5.8. OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES) 5. 9.
Προβλέψεις για συντάξεις και παρόμοιες υποχρεώσεις.
SHELF LIFE, WHEN NECESSARY AFTER RECONSTTTUTION OF THE PRODUCT OR WHEN THE CONTAINER IS OPENED FOR THE FIRST TIME, 6.3.
Λοιπές προβλέψεις.
6. special precautions for disposal of unused products or waste materials derived from such products, if appropriate. " [5]
(Έκτος αν ή εθνική νομοθεσία προβλέπει την εμφάνιση τους στις θέσεις ΣΤ 9 η Θ 9 η και στις δύο).
THE AUTHORISATION PROVIDED FOR IN ARTICLE 3 SHALL BE REFUSED IF, AFTER VERIFICATION OF THE PARTICULARS AND DOCUMENTS USTED IN ARTICLE 4, IT PROVES THAT THE " MEDICINAL PRODUCT " [51 IS HARMFUL IN THE NORMAL CONDITIONS OF USE, OR THAT ITS THERAPEUTIC EFHCACY IS LACKING OR IS INSUTHCIENTLY SUBSTANTIATED BY THE APPLICANT, OR THAT ITS QUALITATIVE AND QUANTITATIVE COMPOSITION IS NOT AS DECLARED.
Ι.
Page 49
Αποθεματικό αναπροσαρμογής
The Member State concerned shpll inform the other Member State and the applicant of its decision to suspend detailed examination of the application in question.
Τακτικό αποθεματικό εφόσον ή εθνική νομοθεσία απαιτεί το σχηματισμό του. 2.
AUTHORISATION SHALL NOT AFFECT THE CIVIL AND CRIMINAL LIABILITY OF THE MANUFACTURER AND, WHERE APPLICABLE, OF THE PERSON RESPONSIBLE FOR PLACING THE •MEDICINAL PRODUCT " [5] ON THE MARKET.
Αποθεματικά για ίδιες μετοχές η ίδια μερίδια εφόσον το απαιτεί ή εθνική νομοθεσία και με την επιφύλαξη των διατάξεων του άρθρου 22 παράγραφος 1 περίπτωση β) της οδηγίας 77/91/ΕΟΚ. 3.
After an authorization has been issued, the person responsible for placing the product on the market must, in respect of the methods of preparation and control provided for in points 4 and 7 of the second paragraph of Article 4, take account of technical and scientific progress and introduce any changes that may be required to enable that medicinal product to be manufactured and checked by means of generally accepted scientific methods.
Αποθεματικά προβλεπόμενα άπό το καταστατικό. 4.
Authorization shall be valid for five years and shall be renewable for fiveyear periods, on application by the holder at least three months before the expiry date and after consideration by the competent authority of a dossier containing in particular details of the data on pharmacovigilance and other information relevant to the monitoring of the medicinal product.
Αποτελέσματα της χρήσεως
SUSPENSION AND REVOCATION OF AUTHORISATION TO MARKET " MEDICINAL PRODUCTS " [5]
Τα Κράτη μέλη μπορούν να επιτρέψουν σε εταιρίες που στην ημερομηνία κλεισίματος του ισολογισμού δεν ξεπερνούν τα όρια των δύο άπό τα παρακάτω τρία κριτήρια:
THE COMPETENT AUTHORITIES OF THE MEMBER STATES SHALL SUSPEND OR REVOKE AN AUTHORISATION TO PLACE A " MEDICINAL PRODUCT " [5] ON THE MARKET WHERE THAT PRODUCT PROVES TO BE HARMFUL IN THE NORMAL CONDITIONS OF USE, OR WHERE ITS THERAPEUTIC EFHCACY IS LACKING, OR WHERE ITS QUALITATIVE AND QUANTITATIVE COMPOSITION IS NOT AS DECLARED.
" - σύνολο ισολογισμού: 2 500 000 Ecu - καθαρό ύψος του κύκλου εργασιών: 5 000 000 Ecu ".
Tfn ­nwrMi­T'* ——*™»κ­**»»» t« ■»ppw·^ »γ **" ^«■™»»*«"*·» fc» ^^»»'*^*™'­»^ and published. w^iVfcÉ­*«Hi^i*MhÉ > th* > n«.y authentic «i—
" Τα κράτη μέλη μπορούν να επιτρέπουν τη μη εφαρμογή του άρθρου 15 παράγραφος 3 στοιχείο α) και παράγραφος 4 στον συνοπτικό ισολογισμό. " [7]
REGULATION OR ADMINISTRATIVE ACTION RELATING TO " MEDICINAL PRODUCTS " [5] HAVE NOT BEEN CARRIED OUT. " [3]
Αρθρο 12
ARΉCLE 12
'Η κατοχή τμήματος του κεφαλαίου μιας εταιρίας θα θεωρηθεί οτι σημαίνει « συμμετοχή » όταν το τμήμα τούτο υπερβαίνει το όριο που καθορίστηκε άπό τα Κράτη μέλη, και το όποιο δεν μπορεί να είναι ανώτερο του 20%.
The consolidated Tendon below is supplied by the C«»Tnntoeion te information only; ttcanfm end published, which continue to be the only authentic
Αρθρο 21
ARTICLE 21
Τα Κράτη μέλη μπορούν, όμως, να επιτρέψουν να περιλαμβάνονται αυτά τα έξοδα στις « υποχρεώσεις ».
MEMBER STATES SHALL PUT INTO FORCE THE MEASURES NEEDED IN ORDER TO COMPLY WITH THIS DiRECTTVE WITHIN EIGHTEEN MONTHS OF ITS NOTIHCATION AND SHALL INFORM THE COMMISSION FORTHWITH.
Οταν τέτοια έξοδα είναι σημαντικά, το ποσό τους πρέπει να αναφέρεται στο προσάρτημα.
MEMBER STATES SHALL ENSURE THAT THEY COMMUNICATE TO THE COMMISSION THE TEXT OF THE MAIN PROVISIONS OF NATIONAL LAW WHICH THEY ADOPT IN THE HELD COVERED BY THIS DIRECTTVE.
Το κατωτέρω κωδικοποιημένα κείμενο δτ)μοσιεύεται αχό την Επιτροπή για ενημερωτικούς σκοπούς- δέν δημιουργεί κανένα δικαίωμα ή υποχρέωση πλην εκείνων που απορρέουν αχό τα νομικά κείμενα τα οποία έχουν νομίμως εγκριθεί και δημοσιευτεί· τα τελευταία είναι τα μόνα αυθεντικά.
" WITHIN THE TIME LIMITS AND UNDER THE CONDITIONS LAID DOWN IN ARTICLE 39 (2) AND (3) OF SECOND DIRECnVE 75/319/EEC, THE RULES LAID DOWN IN THIS DIRECTIVE SHALL BE APPLIED PROGRESSIVELY TO " MEDICINAL PRODUCTS " [5] COVERED BY AN AUTHORIZATION TO PLACE ON THE MARKET BY VIRTUE OF PREVIOUS PROVISIONS. " [2]
ΤΜΗΜΑ5
ARTICLE 25
Για την εμφάνιση των « Αποτελεσμάτων Χρήσεως » τα Κράτη μέλη θα καθιερώσουν ενα η περισσότερους τύπους άπό αυτούς που περιγράφονται στα άρθρα 23 μέχρι 26.
75/319/EEC: SECOND COUNCIL DIRECTIVE OF 20 MAY 1975 ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS
Αν ενα Κράτος μέλος καθιερώσει περισσότερους τύπους μπορεί να επιτρέψει στις εταιρίες να επιλέξουν ενα άπό αυτούς.
OFHCIAL JOURNAL No L 147, 09/06/1975, P. 13 DATE OF NOTIFICATION: 21/05/1975 DATE OF TRANSPOSITION: 21/11/1976; SEE ART. 38
Αρθρο 23
AMENDED BY
Καθαρό υψος του κύκλου εργασιών.
378L0420 78/420/EEC: COUNCIL DIRECTIVE OF 2 MAY 1975 OFHCIAL JOURNAL No L123,11/05/1978, P. 26 DATE OF NCmnCATION: 03/05/1978
Μεταβολές στο απόθεμα των ετοίμων και των ύπό επεξεργασία προϊόντων.
383L0570 83/570/EEC: COUNCIL DIRECTTVE OF 26 OCTOBER 1983 OFHCIAL JOURNAL No L 332, 28/11/1983, P. 1 DATE OF NOTIHCATION: 31/10/1983 DATE OF TRANSPOSITION: 31/10/1985; SEE ART. 4
7. α) Διορθώσεις άξιων των εξόδων ιδρύσεως και παγίων, αϋλων και ενσωμάτων στοιχείων.
389L0343 89/343/EEC: COUNCIL DIRECTTVE OF 3 MAY 1989 OFHCIAL JOURNAL No L142,25/05/1989, P. 16 DATE OF NOTIFICATION: 18/05/1989 DATE OFTRANSPOSmON: 01/01/1992; SEE ART.
Αποτελέσματα άπό τις συνήθεις δραστηριότητες μετά την αφαίρεση των φόρων που τα βαρύνουν.
392L0073 92/73/EEC: COUNCIL DIRECTIVE OF 22 SEPTEMBER 1992 OFHCIAL JOURNAL No L 297,13/10/1992, P. 8 DATE OF NOTIFICATION: 08/10/1992 DATE OF TRANSPOSITION: 31/12/1993; SEE ART. 10
Εκτακτα έσοδα.
APPLICATION FOR AUTHORIZATION TO PLACE PROPRIETARY MEDICINAL PRODUCTS ON THE MARKET
Εκτακτα αποτελέσματα.
THE DUTIES OF THE EXPERTS ACCORDING TO THEIR RESPECTIVE QUALIFICATIONS SHALL BE:
Εξοδα
Page 57
2. α) Αναλωθεισες πρώτες ύλες και αναλώσιμα υλικά, β) Λοιπά έξοδα.
DETAILED REPORTS BY THE EXPERTS SHALL FORM PART OF THE PARTICULARS ACCOMPANYING THE APPLICATION WHICH THE APPLICANT SUBMITS TO THE COMPETENT AUTHORITIES.
Εξοδα προσωπικού: α) Μισθοί και ημερομίσθια.
IN THE EVENT OF ARTICLE 2 OF THIS DffiECTTvE NOT BEING COMPLIED WITH, ARTICLE 5, SECOND PARAGRAPH, OF DffiECTTvE 65/65/EEC SHALL APPLY.
β) Κοινωνικές επιβαρύνσεις, με διαχωρισμό όσων αφορούν συντάξεις.
IN ORDER TO EXAMINE THE APPLICATION SUBMITTED IN ACCORDANCE WITH ARTICLE 4 OF DffiECTTvE 65/65/EEC, THE COMPETENT AUTHORTHES OF THE MEMBER STATES:
4. α) Διορθώσεις άξιων των εξόδων ιδρύσεως και παγίων, αύλων και ενσωμάτων στοιχείων β) Διορθώσεις άξιων παγίων στοιχείων κυκλοφορούντος ενεργητικού, στην έκταση που ξεπερνούν τα συνηθισμένα όρια για την επιχείρηση.
(b) " may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with the second subparagraph of point 7 of Article 4 of Directive 65/65/EEC are satisfactory. " [3]
Λοιπά έξοδα εκμεταλλεύσεως.
MEMBER STATES SHALL TAKE ALL APPROPRIATE MEASURES TO ENSURE THAT:
Τόκοι χρεωστικοί και παρόμοια έξοδα, με διαχωρισμό όσων αφορούν συνδεδεμένες επιχειρήσεις.
In order to facilitate the adoption of common decisions by Member States on the authorization of medicinal products for human use on the basis of the scientific criteria of quality, safety and efficacy, and to achieve thereby the free movement of medicinal products within the Community, a Committee for Proprietary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up.
Φόροι έπί των άπο τελεσμάτων άπό τις συνήθεις δραστηριότητες.
In addition to the other responsibilities conferred upon it by Community law, the Committee shall examine any question relating to the granting, variation, suspension or withdrawal of marketing authorization for a medicinal product which is submitted to it in accordance with this Directive.
Κέρδη άπό τις συνήθεις δραστηριότητες μετά την αφαίρεση των φόρων που τα βαρύνουν.
It shall inform the Member State which granted the initial authorization, the other Member States concerned by the application, the Committee, and the person responsible for placing the medicinal product on the market.
Εκτακτα έξοδα.
*r' to be the only authentic ones.
Φόροι έπί των έκτακτων αποτελεσμάτων.
The Member State concerned, the person responsible for placing the medicinal product on the market or the Commission shall clearly identify the question which is referred to the Committee for consideration and, where appropriate, shall inform the aforementioned person thereof.
Λοιποί φόροι που δεν περιλαμβάνονται στους ανωτέρω λογαριασμούς.
The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the person responsible for placing the medicinal product on the market.
Καθαρό υψος του κύκλου εργασιών.
In case of urgency, on a proposal from its Chairman, the Committee may agree to impose a shorter deadline.
Αύξηση αποθεμάτων των ετοίμων και ύπό επεξεργασία προϊόντων.
When appointing experts, the Committee shall define their tasks and specify the time limit for the completion of these tasks.
'Εργασίες που έγιναν άπό την επιχείρηση για ίδία χρήση της και περιελήφθησαν στο ενεργητικό.
In the cases referred to in Articles 10 and 11, before issuing its opinion, the Committee shall provide the person responsible for placing the medicinal product on the market with an opportunity to present written or oral explanations.
Λοιπά έσοδα έκεταλλευσεως.
Where the opinion of the Committee is that
Το κατωτέρω κωδικοποιημένο κείμενο δημοσιεύεται αχό την Επιτροπή για ενημερωτικούς σκοπούς- δέν δημιουργεί κανένα δικαίωμα ή υποχρέωση πλην εκείνων που απορρέουν από τα νομικά κείμενα τα οποία έχουν νομίμως εγκριθεί και δημοσιευτεί- τα τελευταία είναι τα μόνα αυθεντικά.
»...«i4ii« «ly; *t«.s»» «« r ij Sr f m —^ ί»^«»«. »« «SiHjf^tow« Mp««*« I—, those conferred or tmr—tni by tilt acts formally adoptad and published, which cordimi, to be the only authentic ones.
Αρθρο 25
Article 14
Καθαρό υψος του κύκλου εργασιών.
Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences.
Κόστος παράγωγης παροχών για την πραγματοποίηση του κύκλου εργασιών (περιλαμβανομένων των διορθώσεων άξιων).
A final decision on the application shall be adopted in accordance with the procedure laid down in Article 37b.
Μικτά κέρδη η ζημίες.
These adjustments shall involve the following:
Έξοδα διαθέσεως (περιλαμβανομένων των διορθώσεων άξιων).
A decision adopted in accordance with this Article shall be addressed to the Member States concerned by the matter and to the person responsible for placing the medicinal product on the market.
Εξοδα διοικήσεως (περιλαμβανομένων των διορθώσεων άξιων).
The procedure referred to in Articles 8 to 14 shall not apply in the cases provided for in Article 9 (2) of Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directive 65/65/EEC and 75/319/EEC on the approximation of the laws of the Member States on medicinal products and laying down additional provisions on homeopathic medicinal products.
Εσοδα άπό συμμετοχές, με διαχωρισμό όσων προέρχονται άπό συνδεδεμένες επιχειρήσεις.
Any application by the person responsible for placing the medicinal product on the market to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the medicinal product concerned.
Εσοδα άπό λοιπές επενδύσεις και δάνεια που θεωρούνται πάγια στοιχεία, με διαχωρισμό όσων προέρχονται άπό συνδεδεμένες επιχειρήσεις.
Where a Member State considers that the variation of the terms of a marketing authorization which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of public health, the Member State concerned shall forthwith refer the matter to the Committee for the application of the products laid down in Articles 13 and 14.
Τόκοι πιστωτικοί και παρόμοια έσοδα, με διαχωρισμό όσων προέρχονται άπό συνδεδεμένες επιχειρήσεις.
Without prejudice to the provisions of Article 12, in exceptional cases, where urgent action is essential to protect public health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the medicinal product concerned on its territory.
Διορθώσεις αξίας των παγίων χρηματικών και οικονομικών στοιχείων και των κινητών άξιων.
Articles 15 and 15a shall apply by analogy to medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC (5) before 1 January 1995.
Τόκοι χρηματικοί και παρόμοια έξοδα, με διαχωρισμό όσων προέρχονται άπό συνδεδεμένες επιχειρήσεις.
The Agency shall publish an annual report on the operation of the procedures laid down in this chapter and shall forward that report to the European Parliament and the Council for information.
Φόροι έπί των αποτελεσμάτων άπό τις συνήθεις δραστηριότητες.
The Council shall decide, under the conditions provided for in the Treaty, on the Commission proposal within one year of its submission. " [9]
Αποτελέσματα άπό τις συνήθεις δραστηριότητες μετά την αφαίρεση των φόρων που τα βαρύνουν.
TV coMoBdated «"—*«— K­L*W *■ supplied hy **** Γ«*******«* if internatte, f»y; ** s­sW—« « **gK«» ­mt imposes ~» obligsnons **p»mt· trom ■+"« "»'»««. > ■ imposed «­y the nets fonnaUy adopted end published, which continue to be the only authentic ones. ARHCLE 16
Φόροι έπί των έκτακτων αποτελεσμάτων.
IN ORDER TO OBTAIN THE AUTHORIZAHON REFERRED TO IN ARHCLE 16, THE APPLICANT MUST MEET AT LEAST THE FOLLOWING REQUIREMENTS:
Αποτελέσματα χρήσεως.
THE HOLDER OF AN AUTHORIZAHON REFERRED TO IN ARHCLE 16 SHALL AT LEAST BE OBLIGED:
Το κατωτέρω κωδικοποιημένο κείμενο δημοσιεύεται από την Επιτροπή για ενημερωτικούς σκοπούς· δέν δημιουργεί κανένα δικαίωμα ή υποχρέωση πλην εκείνων που απορρέουν από τα νομικά κείμενα τα οποία έχουν νομίμως εγκριθεί και δημοσιευτεί- τα τελευταία είναι τα μόνα αυθεντικά.
The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 19 (f) shall be adopted in the form of a directive addressed to the Member States, in accordance with the procedure laid down in " Article 37a " [91. Detailed guidelines in line with those principles will be published by the Commission and revised as necessary to take account of technical and scientific progress. " [3]
Εξοδα
ARHCLE 20
Κόστος παράγωγης παροχών για την πραγματοποίηση του κύκλου εργασιών (περιλαμβανομένων των αναπροσαρμογών άξιων).
THE MEMBER STATES SHALL TAKE ALL APPROPRIATE MEASURES TO ENSURE THAT THE HME TAKEN FOR THE PROCEDURE FOR GRANTING THE AUTHORIZAHON REFERRED TO IN ARHCLE 16 DOES NOT EXCEED 90 DAYS FROM THE DAY ON WHICH THE COMPETENT AUTHORITY RECEIVES THE APPLICAHON.
Εξοδα διαθέσεως (περιλαμβανομένων των διορθώσεων άξιων).
IF THE HOLDER OF THE AUTHORIZAHON REQUESTS A CHANGE IN ANY OF THE PARHCULARS REFERRED TO IN ARHCLE 17 (a) AND (b), THE TIME TAKEN FOR THE PROCEDURE RELATING TO THIS REQUEST SHALL NOT EXCEED 30 DAYS.
Εξοδα διοικήσεως (περιλαμβανομένων των διορθώσεων άξιων).
MEMBER STATES MAY REQUIRE FROM THE APPLICANT FURTHER INFORMAHON CONCERNING THE PARHCULARS SUPPLIED PURSUANT TO ARHCLE 17 AND CONCERNING THE QUALIFIED PERSON REFERRED TO IN ARHCLE 21; WHERE THE COMPETENT AUTHORITY CONCERNED EXERCISES THIS RIGHT, APPUCAHON OF THE TIME LIMITS REFERRED TO IN PARAGRAPHS 1 AND 2 SHALL BE SUSPENDED UNTIL THE ADDITIONAL DATA REQUIRED HAVE BEEN SUPPLIED.
Αναπροσαρμογές άξιων των παγίων χρηματικών και οικονομικών στοιχείων, και των κινητών άξιων.
The consolidated Tersion below to supplied by the Cunmüssion te informatine and published, which continue to be the only authentic ones.
Τόκοι χρεωστικοί και παρόμοια έξοδα, με διαχωρισμό όσων προέρχονται άπό συνδεδεμένες επιχειρήσεις.
MEMBER STATES SHALL TAKE ALL APPROPRIATE MEASURES TO ENSURE THAT THE HOLDER OF THE AUTHORIZAHON REFERRED TO IN ARHCLE 16 HAS PERMANENTLY AND CONTINUOUSLY AT HIS DISPOSAL THE SERVICES OF AT LEAST ONE QUALIFIED PERSON, IN ACCORDANCE WITH THE CONDITIONS LAID DOWN IN ARHCLE 23, RESPONSIBLE TN PARHCULAR FOR CARRYING OUT THE DUTTES SPECIFIED IN ARHCLE 22.
Φόροι έπί των αποτελεσμάτων άπό συνήθεις δραστηριότητες.
TF HE PERSONALLY FULFILS THE CONDIHONS LAID DOWN IN ARHCLE 23, THE HOLDER OF THE AUTHORIZAHON MAY HIMSELF ASSUME THE RESPONSIBILHY REFERRED TO IN PARAGRAPH 1.
Κέρδη άπό τις συνήθεις δραστηριότητες μετά την αφαίρεση των φόρων που τα βαρύνουν.
MEMBER STATES SHALL TAKE ALL APPROPRIATE MEASURES TO ENSURE THAT THE QUALIFIED PERSON REFERRED TO IN ARHCLE 21, WITHOUT PREJUDICE TO HIS RELAHONSHTP WITH THE HOLDER OF THE AUTHORIZAHON REFERRED TO IN ARHCLE 16, IS RESPONSIBLE, IN THE CONTEXT OF THE PROCEDURES REFERRED TO IN ARHCLE 25, FOR SECURING:
Φόροι έπί των έκτακτων αποτελεσμάτων.
""^ thfft rffnffirrd or imposed by the acto temafly adopted end published, which continue to be the only authentic ones.
Λοιποί φόροι που δεν περιλαμβάνονται στους ανωτέρω λογαριασμούς.
- APPLIED PHYSICS - GENERAL AND INORGANIC CHEMISTRY - ORGANIC CHEMISTRY - ANALYHCAL CHEMISTRY - PHARMACEUTICAL CHEMISTRY, INCLUDING ANALYSIS OF MEDICINAL PRODUCTS - GENERAL AND APPLIED BIOCHEMISTRY (MEDICAL)
Εσοδα
ARHCLE 24
Καθαρό υψος του κύκλου εργασιών.
A PERSON ENGAGING IN THE ACTIVITIES OF THE PERSON REFERRED TO IN ARHCLE 21 TN A MEMBER STATE AT THE TIME WHEN THIS DffiECTTvE IS BROUGHT INTO FORCE IN THAT STATE BUT WITHOUT COMPLYING WITH THE PROVISIONS OF ARHCLE 23 SHALL BE ELIGIBLE TO CONTINUE TO ENGAGE IN THOSE ACTIVITIES IN THE STATE CONCERNED.
Εσοδα άπό συμμετοχές, με διαχωρισμό όσων προέρχονται άπό συνδεδεμένες επιχειρήσεις.
A PERSON WHO, AT THE TIME WHEN THIS DffiECTTvE IS BROUGHT INTO FORCE, IS ENGAGED IN DIRECT COLLABORAHON WITH A PERSON REFERRED TO IN ARHCLE 21 IN PRODUCTION SUPERVISION ACTIVITIES AND/OR IN QUALHAHVE AND QUANTITATIVE ANALYSIS OF ACTIVE SUBSTANCES AND THE TESTING AND CHECKING NECESSARY TO ENSURE THE QUALITY OF PROPRIETARY MEDICINAL PRODUCTS MAY, FOR A PERIOD OF FIVE YEARS AFTER THIS DffiECHVE HAS BEEN BROUGHT INTO FORCE, BE CONSIDERED AS QUALIFIED TO TAKE UP IN THAT STATE THE DUTIES OF THE PERSON REFERRED TO IN ARHCLE 21 PROVIDED THAT THAT MEMBER STATE ENSURES THAT THE PERSON SHOWS EVIDENCE OF ADEQUATE THEOREHCAL AND PRACTICAL KNOWLEDGE AND HAS ENGAGED IN THE ACHVniES MENTIONED FOR AT LEAST FIVE YEARS.