A new kind of entity reporting to ZSMOPL

The draft amendment on pharmaceutical Law (22.11.2017 version) plans to introduce an obligation of reporting to ZSMOPL by entities authorised for parallel imports: 21a after paragraph 1. 9a The following paragraph shall be added: 9b is added as follows: "9b. The holder of the parallel import shall transmit to the integrated Monitoring system the marketing of medicinal products information on: (1) Any disposal of the medicinal product of an economic operator established in the Pharmacy, Hospital Pharmacy, inpatient department or treatment facility, 2) the stocks of medicinal products, 3) the planned deliveries of medicinal products intended for disposal on The territory of the Republic of Poland, indicating the number of prepackages, in respect of medicinal products complying with the criteria referred to in article 1 (2). The data referred to in article 72b. 72a paragraph 1. 2, point 1 (b) A – E and points 2 to 4.