STATES THE RIGHT TO REQUIRE THAT THE PERSON RESPONSIBLE FOR PLACING THE PRODUCT ON THE MARKET SHOULD BE ESTABLISHED ON THE TERRITORY OF THE MEMBER STATE FOR WHICH THE AUTHORIZATION TO PLACE THE PRODUCT ON THE MARKET IS SOUGHT . SINCE THE DIRECTIVE IS INTENDED TO REDUCE OBSTACLES TO TRADE , ITS SILENCE MAY NOT BE INTERPRETED AS AUTHORIZING MEMBER STATES TO INTRODUCE OR MAINTAIN SUCH A REQUIREMENT .
10 IT SHOULD ALSO BE NOTED THAT THE DIRECTIVE APPLIES ONLY TO PROPRIETARY MEDICINAL PRODUCTS , THAT IS TO SAY , PRODUCTS PREPARED IN ADVANCE , AND MARKETED UNDER A SPECIAL NAME AND IN SPECIAL PACKAGING . AS REGARDS THE PLACE IN WHICH THE PERSON RESPONSIBLE FOR PLACING THE PRODUCT ON THE MARKET IS ESTABLISHED , THE PARTIES HAVE NOT , HOWEVER , PUT FORWARD ANY REASON , IN THE COURSE OF THE PROCEEDINGS , FOR MAKING A DISTINCTION BETWEEN THE SUPERVISION WHICH MAY BE REQUIRED IN THE CASE OF PROPRIETARY MEDICINAL PRODUCTS , ON THE ONE HAND , AND THAT WHICH MAY BE REQUIRED IN THE CASE OF OTHER MEDICINAL PREPARATIONS , ON THE OTHER .
11 WITH REGARD TO ARTICLE 36 OF THE TREATY , IT IS APPARENT THAT THE OBJECTIVES THAT THE GERMAN GOVERNMENT WISHES TO ACHIEVE IN RELATION TO THE SURVEILLANCE OF MEDICINAL PREPARATIONS AND THE AVAILABILITY OF INFORMATION IN CASE OF ACCIDENT COULD BE FULLY MET BY APPROPRIATE ORGANIZATIONAL MEASURES AT THE STAGE OF THE EXAMINATION OF APPLICATIONS AND THE ISSUE OF THE AUTHORIZATION TO PLACE THE PRODUCT ON THE MARKET , WITHOUT THERE BEING ANY NEED TO HAVE A REPRESENTATIVE ON THE NATIONAL TERRITORY AND STILL LESS WITHOUT THERE BEING ANY NEED FOR A PHARMACEUTICAL UNDERTAKING TO ACT AS INTERMEDIARY . THE PROCEDURE FOR OBTAINING AN AUTHORIZATION TO PLACE A PRODUCT ON THE MARKET NECESSARILY IMPLIES CONTACTS BETWEEN THE COMPETENT AUTHORITIES AND THE PERSON RESPONSIBLE FOR PLACING THAT PRODUCT ON THE MARKET , ESTABLISHED IN ANOTHER MEMBER STATE , AND THESE CAN BE RENEWED , IF NEED BE , IF DIFFICULTIES ARISE IN THE COURSE OF MARKETING .
12 FURTHERMORE , THE PROCEDURE OF APPLYING FOR AN AUTHORIZATION TO PLACE A PRODUCT ON THE MARKET HAS A PREVENTIVE EFFECT AND THE POSSIBILITY THAT THE AUTHORIZATION MIGHT BE SUSPENDED OR REVOKED IS AN INCENTIVE TO THE MANUFACTURERS AND THE PERSON RESPONSIBLE FOR PLACING PRODUCTS ON THE MARKET TO COMPLY WITH THE RULES IN FORCE , GIVEN THE IMPACT OF SUCH A DECISION ON THE UNDERTAKING AND ON ITS SALES . ALSO , WHERE MEDICINAL PREPARATIONS IMPORTED FROM ANOTHER MEMBER STATE ARE A SOURCE OF DANGER , THE AUTHORITIES OF THE IMPORTING MEMBER STATE WILL NOT FAIL TO CONTACT THE COMPETENT AUTHORITIES IN THE MEMBER STATES OF PRODUCTION WHICH CAN , IN TURN , TAKE THE NECESSARY MEASURES . THERE IS ALSO THE POSSIBILITY OF INFORMING THE CIRCLES CONCERNED , PARTICULARLY DOCTORS AND PHARMACISTS AND , IN THE EVENT OF EMERGENCY , OF WARNING THE PUBLIC DIRECTLY THROUGH THE PRESS , RADIO AND TELEVISION .
13 WITH